Trial Outcomes & Findings for Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes (NCT NCT03955952)
NCT ID: NCT03955952
Last Updated: 2026-08-03
Results Overview
First occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation
Recruitment status
COMPLETED
Target enrollment
91700 participants
Primary outcome timeframe
From index date through a maximum of 8 years
Results posted on
2026-08-03
Participant Flow
Retrospective chart review of 287, 428 patients with Diabetes in the Cleveland Clinic health system between 1998-2017
Participant milestones
| Measure |
Bariatric Surgery
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
|---|---|---|
|
Overall Study
STARTED
|
2757
|
88943
|
|
Overall Study
COMPLETED
|
2287
|
11435
|
|
Overall Study
NOT COMPLETED
|
470
|
77508
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Bariatric Surgery
n=2287 Participants
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
n=11435 Participants
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
Total
n=13722 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 years
n=20 Participants
|
54.8 years
n=20 Participants
|
54.4 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
1499 Participants
n=20 Participants
|
7339 Participants
n=20 Participants
|
8838 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
788 Participants
n=20 Participants
|
4096 Participants
n=20 Participants
|
4884 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
441 Participants
n=20 Participants
|
2804 Participants
n=20 Participants
|
3245 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
1734 Participants
n=20 Participants
|
7994 Participants
n=20 Participants
|
9728 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
54 Participants
n=20 Participants
|
234 Participants
n=20 Participants
|
288 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
58 Participants
n=20 Participants
|
403 Participants
n=20 Participants
|
461 Participants
n=40 Participants
|
|
BMI
|
45.1 kg/m^2
n=20 Participants
|
42.6 kg/m^2
n=20 Participants
|
42.9 kg/m^2
n=40 Participants
|
PRIMARY outcome
Timeframe: From index date through a maximum of 8 yearsPopulation: All enrolled participants
First occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation
Outcome measures
| Measure |
Bariatric Surgery
n=2287 Participants
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
n=11435 Participants
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
|---|---|---|
|
All-Cause Mortality and/or Cardiovascular Outcomes
|
30.8 percentage of participants
Interval 27.6 to 34.0
|
47.7 percentage of participants
Interval 46.1 to 49.2
|
SECONDARY outcome
Timeframe: From index date through a maximum of 8 yearsPopulation: All enrolled participants
First occurrence of all-cause mortality, myocardial infarction or ischemic stroke
Outcome measures
| Measure |
Bariatric Surgery
n=2287 Participants
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
n=11435 Participants
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
|---|---|---|
|
Major Adverse Cardiovascular Event (MACE-3)
|
17 percentage of participants
Interval 14.3 to 19.7
|
27.6 percentage of participants
Interval 26.2 to 29.0
|
SECONDARY outcome
Timeframe: From index date through a maximum of 8 yearsPopulation: All enrolled participants
Occurrence of death from any cause
Outcome measures
| Measure |
Bariatric Surgery
n=2287 Participants
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
n=11435 Participants
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
|---|---|---|
|
All-Cause Mortality
|
4.9 percentage of participants
Interval 7.8 to 12.2
|
9.72 percentage of participants
Interval 16.6 to 19.0
|
SECONDARY outcome
Timeframe: From index date through a maximum of 8 yearsPopulation: Enrolled participants without a history of the outcome (coronary disease events)
First occurrence of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting
Outcome measures
| Measure |
Bariatric Surgery
n=2050 Participants
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
n=10331 Participants
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
|---|---|---|
|
Coronary Disease Events
|
7.9 percentage of participants
Interval 5.9 to 9.8
|
11.6 percentage of participants
Interval 10.5 to 12.6
|
SECONDARY outcome
Timeframe: From index date through a maximum of 8 yearsPopulation: Enrolled participants without a history of the outcome (cerebrovascular events)
First occurrence of ischemic or hemorrhagic stroke, carotid stenting or endarterectomy
Outcome measures
| Measure |
Bariatric Surgery
n=2245 Participants
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
n=11077 Participants
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
|---|---|---|
|
Cerebrovascular Events
|
4.1 percentage of participants
Interval 2.7 to 5.5
|
5.6 percentage of participants
Interval 4.9 to 6.3
|
SECONDARY outcome
Timeframe: From index date through a maximum of 8 yearsPopulation: Enrolled participants without a history of the outcome (heart failure)
First occurrence of heart failure
Outcome measures
| Measure |
Bariatric Surgery
n=2049 Participants
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
n=10093 Participants
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
|---|---|---|
|
Heart Failure
|
6.8 percentage of participants
Interval 4.9 to 8.6
|
18.9 percentage of participants
Interval 17.6 to 20.2
|
SECONDARY outcome
Timeframe: From index date through a maximum of 8 yearsPopulation: Enrolled participants without a history of the outcome (nephropathy)
First occurrence of nephropathy defined as \>=2 measures of estimated Glomerular Filtration Rate (eGFR) \<60 ml/min/1.73m\^2 separated by at least 90 days without intervening values \>=60
Outcome measures
| Measure |
Bariatric Surgery
n=1937 Participants
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
n=9190 Participants
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
|---|---|---|
|
Development of Nephropathy
|
6.1 percentage of participants
Interval 4.4 to 7.8
|
16.3 percentage of participants
Interval 15.0 to 17.6
|
SECONDARY outcome
Timeframe: From index date through a maximum of 8 yearsPopulation: Enrolled participants without a history of the outcome (atrial fibrillation)
First occurrence of atrial fibrillation defined by the following codes: International Classification of Diseases ICD-9: 427.31 ICD-10: i48.0, i48.1, i48.2, i48.91 Current Procedural Terminology (CPT): 93650, 93653, 93656, 93657
Outcome measures
| Measure |
Bariatric Surgery
n=2135 Participants
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
n=10734 Participants
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
|---|---|---|
|
Atrial Fibrillation
|
7.9 percentage of participants
Interval 6.1 to 9.7
|
13.6 percentage of participants
Interval 12.5 to 14.7
|
Adverse Events
Bariatric Surgery
Serious events: 169 serious events
Other events: 0 other events
Deaths: 112 deaths
Non-Surgical Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1111 deaths
Serious adverse events
| Measure |
Bariatric Surgery
n=2287 participants at risk
Patients with type 2 diabetes with BMI \>=30 that underwent bariatric surgery
Bariatric Surgery: Patients chosen using the following codes:
Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085
|
Non-Surgical Control
Matched non-surgical controls with type 2 diabetes and BMI \>=30
|
|---|---|---|
|
Renal and urinary disorders
Renal Failure requiring dialysis
|
0.17%
4/2287 • Number of events 4 • 8 years
Only mortality was reported for both groups. 90-day postoperative adverse events of bariatric surgery were reported. Adverse events were not collected real time and were based on retrospective chart review. Due to this method, no distinction was made between Serious and Non-Serious as the study team did not feel they had enough information to adequately assess the situation. Adverse events in the nonsurgical group (beside the mortality) are not reported.
|
—
0/0 • 8 years
Only mortality was reported for both groups. 90-day postoperative adverse events of bariatric surgery were reported. Adverse events were not collected real time and were based on retrospective chart review. Due to this method, no distinction was made between Serious and Non-Serious as the study team did not feel they had enough information to adequately assess the situation. Adverse events in the nonsurgical group (beside the mortality) are not reported.
|
|
Vascular disorders
Bleeding requiring transfusion
|
3.0%
68/2287 • Number of events 68 • 8 years
Only mortality was reported for both groups. 90-day postoperative adverse events of bariatric surgery were reported. Adverse events were not collected real time and were based on retrospective chart review. Due to this method, no distinction was made between Serious and Non-Serious as the study team did not feel they had enough information to adequately assess the situation. Adverse events in the nonsurgical group (beside the mortality) are not reported.
|
—
0/0 • 8 years
Only mortality was reported for both groups. 90-day postoperative adverse events of bariatric surgery were reported. Adverse events were not collected real time and were based on retrospective chart review. Due to this method, no distinction was made between Serious and Non-Serious as the study team did not feel they had enough information to adequately assess the situation. Adverse events in the nonsurgical group (beside the mortality) are not reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Adverse Events
|
2.5%
58/2287 • Number of events 58 • 8 years
Only mortality was reported for both groups. 90-day postoperative adverse events of bariatric surgery were reported. Adverse events were not collected real time and were based on retrospective chart review. Due to this method, no distinction was made between Serious and Non-Serious as the study team did not feel they had enough information to adequately assess the situation. Adverse events in the nonsurgical group (beside the mortality) are not reported.
|
—
0/0 • 8 years
Only mortality was reported for both groups. 90-day postoperative adverse events of bariatric surgery were reported. Adverse events were not collected real time and were based on retrospective chart review. Due to this method, no distinction was made between Serious and Non-Serious as the study team did not feel they had enough information to adequately assess the situation. Adverse events in the nonsurgical group (beside the mortality) are not reported.
|
|
Vascular disorders
Venous Thrombosis
|
0.96%
22/2287 • Number of events 22 • 8 years
Only mortality was reported for both groups. 90-day postoperative adverse events of bariatric surgery were reported. Adverse events were not collected real time and were based on retrospective chart review. Due to this method, no distinction was made between Serious and Non-Serious as the study team did not feel they had enough information to adequately assess the situation. Adverse events in the nonsurgical group (beside the mortality) are not reported.
|
—
0/0 • 8 years
Only mortality was reported for both groups. 90-day postoperative adverse events of bariatric surgery were reported. Adverse events were not collected real time and were based on retrospective chart review. Due to this method, no distinction was made between Serious and Non-Serious as the study team did not feel they had enough information to adequately assess the situation. Adverse events in the nonsurgical group (beside the mortality) are not reported.
|
|
Cardiac disorders
Cardiac events
|
0.74%
17/2287 • Number of events 17 • 8 years
Only mortality was reported for both groups. 90-day postoperative adverse events of bariatric surgery were reported. Adverse events were not collected real time and were based on retrospective chart review. Due to this method, no distinction was made between Serious and Non-Serious as the study team did not feel they had enough information to adequately assess the situation. Adverse events in the nonsurgical group (beside the mortality) are not reported.
|
—
0/0 • 8 years
Only mortality was reported for both groups. 90-day postoperative adverse events of bariatric surgery were reported. Adverse events were not collected real time and were based on retrospective chart review. Due to this method, no distinction was made between Serious and Non-Serious as the study team did not feel they had enough information to adequately assess the situation. Adverse events in the nonsurgical group (beside the mortality) are not reported.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place