Trial Outcomes & Findings for Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes (NCT NCT00432809)

Last Updated: 2017-08-23

Results Overview

The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).

Recruitment status

COMPLETED

Study phase

Target enrollment

150 participants

Primary outcome timeframe

1 year

Results posted on

2017-08-23

Participant Flow

Study recruitment began December 2006 and the last patient was enrolled January 2011. Patients were recruited from the Bariatric and Diabetes Outpatient clinic.

68 patients screened fail prior to randomization due to not meeting inclusion criteria.

Participant milestones

Participant milestones
Measure	Medical Therapy Intensive medical therapy for diabetes	Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1 Year Follow-up STARTED	50	50	50
1 Year Follow-up COMPLETED	41	50	49
1 Year Follow-up NOT COMPLETED	9	0	1
2 Year Sub-study STARTED	20	20	20
2 Year Sub-study COMPLETED	17	18	19
2 Year Sub-study NOT COMPLETED	3	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Medical Therapy Intensive medical therapy for diabetes	Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
1 Year Follow-up Misses 9 and 12 month visit	2	0	0
1 Year Follow-up Withdrawal by Subject	7	0	1

Baseline Characteristics

Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medical Therapy n=50 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=50 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=99 Participants	50 Participants n=107 Participants	50 Participants n=206 Participants	150 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Continuous	49.7 years STANDARD_DEVIATION 7.4 • n=99 Participants	48.3 years STANDARD_DEVIATION 8.4 • n=107 Participants	47.9 years STANDARD_DEVIATION 8.0 • n=206 Participants	48.6 years STANDARD_DEVIATION 7.9 • n=7 Participants
Sex: Female, Male Female	31 Participants n=99 Participants	29 Participants n=107 Participants	39 Participants n=206 Participants	99 Participants n=7 Participants
Sex: Female, Male Male	19 Participants n=99 Participants	21 Participants n=107 Participants	11 Participants n=206 Participants	51 Participants n=7 Participants
Race/Ethnicity, Customized Caucasian	37 participants n=99 Participants	37 participants n=107 Participants	36 participants n=206 Participants	110 participants n=7 Participants
Race/Ethnicity, Customized Black/African American	12 participants n=99 Participants	13 participants n=107 Participants	14 participants n=206 Participants	39 participants n=7 Participants
Race/Ethnicity, Customized Asian	1 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants	1 participants n=7 Participants
Region of Enrollment United States	50 participants n=99 Participants	50 participants n=107 Participants	50 participants n=206 Participants	150 participants n=7 Participants
Duration of diabetes	8.9 Years STANDARD_DEVIATION 5.8 • n=99 Participants	8.2 Years STANDARD_DEVIATION 5.5 • n=107 Participants	8.5 Years STANDARD_DEVIATION 4.8 • n=206 Participants	8.5 Years STANDARD_DEVIATION 5.4 • n=7 Participants
Use of insulin Insulin dependent	22 participants n=99 Participants	22 participants n=107 Participants	22 participants n=206 Participants	66 participants n=7 Participants
Use of insulin Non-insulin dependent	28 participants n=99 Participants	28 participants n=107 Participants	28 participants n=206 Participants	84 participants n=7 Participants
body-mass index	36.8 kg/m2 STANDARD_DEVIATION 3.0 • n=99 Participants	37.0 kg/m2 STANDARD_DEVIATION 3.3 • n=107 Participants	36.2 kg/m2 STANDARD_DEVIATION 3.9 • n=206 Participants	36.7 kg/m2 STANDARD_DEVIATION 3.4 • n=7 Participants
Body-mass index < 35 BMI < 35	19 participants n=99 Participants	14 participants n=107 Participants	18 participants n=206 Participants	51 participants n=7 Participants
Body-mass index < 35 BMI > / = 35	31 participants n=99 Participants	36 participants n=107 Participants	32 participants n=206 Participants	99 participants n=7 Participants
Body weight	106.5 kg STANDARD_DEVIATION 14.7 • n=99 Participants	106.7 kg STANDARD_DEVIATION 14.8 • n=107 Participants	100.8 kg STANDARD_DEVIATION 16.4 • n=206 Participants	104.6 kg STANDARD_DEVIATION 15.4 • n=7 Participants
Waist circumference	114.5 cm STANDARD_DEVIATION 9.4 • n=99 Participants	116.4 cm STANDARD_DEVIATION 9.2 • n=107 Participants	114.0 cm STANDARD_DEVIATION 10.4 • n=206 Participants	115.0 cm STANDARD_DEVIATION 9.7 • n=7 Participants
Fasting glucose	169.6 mg/dL STANDARD_DEVIATION 59.1 • n=99 Participants	188.9 mg/dL STANDARD_DEVIATION 67.6 • n=107 Participants	177.6 mg/dL STANDARD_DEVIATION 70.3 • n=206 Participants	178.7 mg/dL STANDARD_DEVIATION 65.9 • n=7 Participants
Smoker Smoker	15 Participants n=99 Participants	20 Participants n=107 Participants	11 Participants n=206 Participants	46 Participants n=7 Participants
Smoker Non-smoker	35 Participants n=99 Participants	30 Participants n=107 Participants	39 Participants n=206 Participants	104 Participants n=7 Participants
Metabolic syndrome Yes	46 participants n=99 Participants	45 participants n=107 Participants	47 participants n=206 Participants	138 participants n=7 Participants
Metabolic syndrome No	4 participants n=99 Participants	5 participants n=107 Participants	3 participants n=206 Participants	12 participants n=7 Participants
History of dyslipidemia Yes	36 participants n=99 Participants	44 participants n=107 Participants	40 participants n=206 Participants	120 participants n=7 Participants
History of dyslipidemia No	14 participants n=99 Participants	6 participants n=107 Participants	10 participants n=206 Participants	30 participants n=7 Participants
History of hypertension Yes	26 participants n=99 Participants	35 participants n=107 Participants	30 participants n=206 Participants	91 participants n=7 Participants
History of hypertension No	24 participants n=99 Participants	15 participants n=107 Participants	20 participants n=206 Participants	59 participants n=7 Participants
Systolic blood pressure	137.5 mmHg STANDARD_DEVIATION 17.4 • n=99 Participants	134.6 mmHg STANDARD_DEVIATION 18.7 • n=107 Participants	136.2 mmHg STANDARD_DEVIATION 18.8 • n=206 Participants	136.1 mmHg STANDARD_DEVIATION 18.3 • n=7 Participants
Diastolic blood pressure	83.7 mmHg STANDARD_DEVIATION 11.5 • n=99 Participants	81.8 mmHg STANDARD_DEVIATION 10.2 • n=107 Participants	82.1 mmHg STANDARD_DEVIATION 11.5 • n=206 Participants	82.5 mmHg STANDARD_DEVIATION 11.0 • n=7 Participants
High-density lipoprotein cholesterol	46.3 mg/dL STANDARD_DEVIATION 13.2 • n=99 Participants	46.2 mg/dL STANDARD_DEVIATION 13.4 • n=107 Participants	44.5 mg/dL STANDARD_DEVIATION 11.9 • n=206 Participants	45.7 mg/dL STANDARD_DEVIATION 12.8 • n=7 Participants
Triglycerides	169.0 mg/dL n=99 Participants	167.0 mg/dL n=107 Participants	157.0 mg/dL n=206 Participants	166.5 mg/dL n=7 Participants
Diabetic medication - Biguanides Taking Biguanides	46 participants n=99 Participants	42 participants n=107 Participants	42 participants n=206 Participants	130 participants n=7 Participants
Diabetic medication - Biguanides Not taking Biguanides	4 participants n=99 Participants	8 participants n=107 Participants	8 participants n=206 Participants	20 participants n=7 Participants
Diabetes medication - Thiazolidinedione (TZD's) Taking TZD's	20 participants n=99 Participants	25 participants n=107 Participants	17 participants n=206 Participants	62 participants n=7 Participants
Diabetes medication - Thiazolidinedione (TZD's) Not taking TZD's	30 participants n=99 Participants	25 participants n=107 Participants	33 participants n=206 Participants	88 participants n=7 Participants
Diabetes medication - Incretin Mimetics Taking Incretin Mimetics	24 participants n=99 Participants	19 participants n=107 Participants	21 participants n=206 Participants	64 participants n=7 Participants
Diabetes medication - Incretin Mimetics Not taking Incretin Mimetics	26 participants n=99 Participants	31 participants n=107 Participants	29 participants n=206 Participants	86 participants n=7 Participants
Diabetes medication - Secretagogues Taking Secretagogues	18 participants n=99 Participants	17 participants n=107 Participants	19 participants n=206 Participants	54 participants n=7 Participants
Diabetes medication - Secretagogues Not taking Secretagogues	32 participants n=99 Participants	33 participants n=107 Participants	31 participants n=206 Participants	96 participants n=7 Participants
Number of Diabetic Medications 0	1 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants	3 participants n=7 Participants
Number of Diabetic Medications 1	8 participants n=99 Participants	10 participants n=107 Participants	11 participants n=206 Participants	29 participants n=7 Participants
Number of Diabetic Medications 2	11 participants n=99 Participants	13 participants n=107 Participants	14 participants n=206 Participants	38 participants n=7 Participants
Number of Diabetic Medications 3	16 participants n=99 Participants	12 participants n=107 Participants	13 participants n=206 Participants	41 participants n=7 Participants
Number of Diabetic Medications > / = 4	14 participants n=99 Participants	14 participants n=107 Participants	11 participants n=206 Participants	39 participants n=7 Participants
Cardiovascular medication - Lipid Lowering Agents Taking Lipid Lowering Agent	41 participants n=99 Participants	43 participants n=107 Participants	39 participants n=206 Participants	123 participants n=7 Participants
Cardiovascular medication - Lipid Lowering Agents Not taking Lipid Lowering Agent	9 participants n=99 Participants	7 participants n=107 Participants	11 participants n=206 Participants	27 participants n=7 Participants
Cardiovascular medication - Beta blocker Taking Beta Blocker	9 participant n=99 Participants	9 participant n=107 Participants	6 participant n=206 Participants	24 participant n=7 Participants
Cardiovascular medication - Beta blocker Not taking Beta Blocker	41 participant n=99 Participants	41 participant n=107 Participants	44 participant n=206 Participants	126 participant n=7 Participants
Cardiovascular medications - ACE Inhibitors or ARB Taking ACE Inhibitor or ARB	30 participant n=99 Participants	32 participant n=107 Participants	25 participant n=206 Participants	87 participant n=7 Participants
Cardiovascular medications - ACE Inhibitors or ARB Not taking ACE Inhibitor or ARB	20 participant n=99 Participants	18 participant n=107 Participants	25 participant n=206 Participants	63 participant n=7 Participants
Cardiovascular medication - Anticoagulant Taking Anticoagulants	26 participant n=99 Participants	21 participant n=107 Participants	16 participant n=206 Participants	63 participant n=7 Participants
Cardiovascular medication - Anticoagulant Not taking Anticoagulants	24 participant n=99 Participants	29 participant n=107 Participants	34 participant n=206 Participants	87 participant n=7 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Modified intent-to-treat (ITT) population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

The proportion of subjects with a glycated hemoglobin level of 6% or less(with or without diabetes medications) 12 months after randomization (baseline measure).

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.	5 participants	21 participants	18 participants

PRIMARY outcome

Timeframe: 1 year

Population: Modified intent-to-treat population consists of all randomized patients that initiate treatment (surgery for those randomized to surgery and medical treatment for those randomized to medical treatment). All analyses conducted in the modified ITT population. Primary analysis also conducted in per protocol population as a sensitivity analysis.

The proportion of subjects with a glycated hemoglobin level of 6% or less(without diabetes medications) 12 months after randomization.

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications	0 participants	21 participants	13 participants

SECONDARY outcome

Timeframe: 1, 2, and 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 2, and 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 2, and 5 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year - baseline

Change in glycated hemoglobin(HbA1c)from baseline in percentage points / percent change

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Change in Glycated Hemoglobin (HbA1c)	-1.4 percentage points of glycated hemoglobin Standard Deviation 1.5	-2.9 percentage points of glycated hemoglobin Standard Deviation 1.6	-2.9 percentage points of glycated hemoglobin Standard Deviation 1.8

SECONDARY outcome

Timeframe: 1 year

Fasting Plasma Glucose measured in mg/dL.

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Fasting Plasma Glucose	120 mg/dL Interval 97.0 to 154.0	99 mg/dL Interval 83.0 to 121.0	97 mg/dL Interval 84.0 to 114.0

SECONDARY outcome

Timeframe: 1 year

Mean glycated hemoglobin (HbA1c) at 12 months for each of the 3 groups, in percentage points

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Glycated Hemoglobin (HbA1c)	7.5 percentage points of glycated hemoglobin Standard Deviation 1.8	6.4 percentage points of glycated hemoglobin Standard Deviation 0.9	6.6 percentage points of glycated hemoglobin Standard Deviation 1.0

SECONDARY outcome

Timeframe: 1 year

Body weight in kilograms (kg) measured at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Body Weight	99.0 kg Standard Deviation 16.4	77.3 kg Standard Deviation 13.0	75.5 kg Standard Deviation 12.9

SECONDARY outcome

Timeframe: 1 year

Mean change in body weight from baseline measured in kilograms (kg)

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Change in Body Weight From Baseline	-5.4 kg Standard Deviation 8.0	-29.4 kg Standard Deviation 8.9	-25.1 kg Standard Deviation 8.5

SECONDARY outcome

Timeframe: 1 year

Body Mass Index (BMI) at 12 months measured as kg/m2

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Body Mass Index (BMI)	34.4 kg/m2 Standard Deviation 3.7	26.8 kg/m2 Standard Deviation 3.2	27.2 kg/m2 Standard Deviation 3.5

SECONDARY outcome

Timeframe: 1 year

Change in Body Mass Index (BMI) at 12 months, measured in kg/m2

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Change in Body Mass Index (BMI)	-1.9 kg/m2 Standard Deviation 2.9	-10.2 kg/m2 Standard Deviation 3.1	-9.0 kg/m2 Standard Deviation 2.7

SECONDARY outcome

Timeframe: 1 year

Change in Systolic Blood Pressure (SBP) at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Change in Systolic Blood Pressure (SBP)	-3.9 mm Hg Standard Deviation 14.7	-2.4 mm Hg Standard Deviation 18.7	-5.1 mm Hg Standard Deviation 17.0

SECONDARY outcome

Timeframe: 1 year

Percent change in high-density lipoprotein (HDL) at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Change in High-density Lipoprotein (HDL)	11.3 mg/dL Standard Deviation 25.7	28.5 mg/dL Standard Deviation 22.7	28.4 mg/dL Standard Deviation 21.9

SECONDARY outcome

Timeframe: 1 year

Median percent change in triglycerides at 12 months from baseline measure

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Change in Triglycerides	-14 mg/dL Interval -40.0 to 3.0	-44 mg/dL Interval -65.0 to -16.0	-42 mg/dL Interval -56.0 to 0.0

SECONDARY outcome

Timeframe: 1 year

Median percent change in high-sensitivity C-reactive protein (hs-CRP)from baseline at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Change in High-sensitivity C-reactive Protein (Hs-CRP)	-33.2 mg/L Interval -71.0 to 0.0	-84 mg/L Interval -91.0 to -59.0	-80 mg/L Interval -90.0 to -63.0

SECONDARY outcome

Timeframe: 1 year

Number of participants taking insulin at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Diabetes Medication - Use of Insulin	15 participants	2 participants	4 participants

SECONDARY outcome

Timeframe: 1 year

Number of participants taking Biguanides at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Diabetes Medication - Use of Biguanides	38 participants	10 participants	19 participants

SECONDARY outcome

Timeframe: 1 year

Number of participants using thiazolidinedione at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Diabetes Medication - Use of Thiazolidinedione	20 participants	0 participants	5 participants

SECONDARY outcome

Timeframe: 1 year

Number of participants taking Incretin Mimetics

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Diabetes Medication - Use of Incretin Mimetics	34 participants	1 participants	10 participants

SECONDARY outcome

Timeframe: 1 year

Number of participants taking Secretagogues at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Diabetes Medication - Use of Secretagogue	10 participants	1 participants	5 participants

SECONDARY outcome

Timeframe: 1 year

Number of participants taking Lipid lowering agents at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Cardiovascular Medications - Lipid Lowering Agents	36 participants	13 participants	19 participants

SECONDARY outcome

Timeframe: 1 year

Number of participants taking Beta Blockers at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Cardiovascular Medications - Beta Blocker	5 participants	9 participants	3 participants

SECONDARY outcome

Timeframe: 1 year

Number of participants taking Angiotensin-converting enzyme (ACE Inhibitor) or Angiotensin-receptor blocker (ARB) at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)	26 participants	9 participants	11 participants

SECONDARY outcome

Timeframe: 1 year

Number of participants taking anticoagulants at 12 months

Outcome measures

Outcome measures
Measure	Medical Therapy n=41 Participants Intensive medical therapy for diabetes	Gastric Bypass n=50 Participants Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 Participants Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Cardiovascular Medications - Anticoagulants	24 participants	1 participants	8 participants

Adverse Events

Medical Therapy

Serious events: 4 serious events

Other events: 42 other events

Deaths: 0 deaths

Gastric Bypass

Serious events: 16 serious events

Other events: 48 other events

Deaths: 0 deaths

Sleeve Gastrectomy

Serious events: 7 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Philip Schauer

Cleveland Clinic

Phone: 216-444-4794

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Medical Therapy n=43 participants at risk Intensive medical therapy for diabetes	Gastric Bypass n=50 participants at risk Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy	Sleeve Gastrectomy n=49 participants at risk Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
Surgical and medical procedures Intravenous treatment for dehydration	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	8.0% 4/50 • Number of events 4 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	4.1% 2/49 • Number of events 2 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Surgical and medical procedures Reoperation	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	6.0% 3/50 • Number of events 3 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/49 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Surgical and medical procedures Transfusion	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/50 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/49 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Investigations Hemoglobin decrease > / = 5 g/dl	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/50 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/49 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Surgical and medical procedures Gastrointestinal leak	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/50 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/49 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Renal and urinary disorders Transient renal insufficiency	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/50 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/49 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Hepatobiliary disorders Cholelithiasis	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/50 • Number of events 2 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/49 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Cardiac disorders Arrhythmia or palpitations	4.7% 2/43 • Number of events 2 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/50 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/49 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/50 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/49 • Number of events 2 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Endocrine disorders Ketoacidosis	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/50 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/49 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Surgical and medical procedures Wound infection	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/50 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/49 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Infections and infestations Cellulitis	2.3% 1/43 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/50 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/49 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	4.0% 2/50 • Number of events 2 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/49 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Renal and urinary disorders Kidney stone	2.3% 1/43 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/50 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/49 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.
Surgical and medical procedures Hernia	0.00% 0/43 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	2.0% 1/50 • Number of events 1 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.	0.00% 0/49 • 1 year Subjects systematically assessed every 3 months during routine study visits, or sooner if an event occurred. Number of Medical Therapy subjects (43) includes 2 subjects that had an event and withdrew consent prior to their 9 month visit. 7 subjects withdrew immediately after randomization. 1 Sleeve Gastrectomy subject withdrew prior to surgery.