Trial Outcomes & Findings for EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial (NCT NCT04531176)
NCT ID: NCT04531176
Last Updated: 2024-09-19
Results Overview
All relevant time points used in the calculation in the Time Frame between baseline and 12 months. Measured in the mean Change in body weight between baseline and 12 months measured in percentage (%) of body weight loss
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
74 participants
Primary outcome timeframe
12 Months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Obesity-centric Approach + AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
Weight Management Program (WMP): Weight Management Program (WMP)
Phentermine / Topiramate Extended Release Oral Capsule: Medication for chronic weight management (Rx)
naltrexone/bupropion extended-release: Medication for chronic weight management (Rx)
liraglutide 3.0 mg: Medication for chronic weight management (Rx)
Orlistat: Medication for chronic weight management (Rx)
|
Obesity-centric Approach Without AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Weight Management Program (WMP): Weight Management Program (WMP)
|
Usual Care Approach (Comorbidity-centric Approach)
Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.
Traditional care: Traditional care
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
24
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
24
|
26
|
24
|
Reasons for withdrawal
| Measure |
Obesity-centric Approach + AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
Weight Management Program (WMP): Weight Management Program (WMP)
Phentermine / Topiramate Extended Release Oral Capsule: Medication for chronic weight management (Rx)
naltrexone/bupropion extended-release: Medication for chronic weight management (Rx)
liraglutide 3.0 mg: Medication for chronic weight management (Rx)
Orlistat: Medication for chronic weight management (Rx)
|
Obesity-centric Approach Without AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Weight Management Program (WMP): Weight Management Program (WMP)
|
Usual Care Approach (Comorbidity-centric Approach)
Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.
Traditional care: Traditional care
|
|---|---|---|---|
|
Overall Study
Study was stopped early
|
24
|
26
|
24
|
Baseline Characteristics
EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial
Baseline characteristics by cohort
| Measure |
Obesity-centric Approach + AOM
n=24 Participants
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
Weight Management Program (WMP): Weight Management Program (WMP)
Phentermine / Topiramate Extended Release Oral Capsule: Medication for chronic weight management (Rx)
naltrexone/bupropion extended-release: Medication for chronic weight management (Rx)
liraglutide 3.0 mg: Medication for chronic weight management (Rx)
Orlistat: Medication for chronic weight management (Rx)
|
Obesity-centric Approach Without AOM
n=23 Participants
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Weight Management Program (WMP): Weight Management Program (WMP)
|
Usual Care Approach (Comorbidity-centric Approach)
n=23 Participants
Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.
Traditional care: Traditional care
|
Total
n=70 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
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
70 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
|
53.5 years
n=99 Participants
|
53.5 years
n=107 Participants
|
53 years
n=206 Participants
|
53.5 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
24 participants
n=99 Participants
|
23 participants
n=107 Participants
|
23 participants
n=206 Participants
|
70 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsAll relevant time points used in the calculation in the Time Frame between baseline and 12 months. Measured in the mean Change in body weight between baseline and 12 months measured in percentage (%) of body weight loss
Outcome measures
| Measure |
Obesity-centric Approach + AOM
n=23 Participants
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
Weight Management Program (WMP): Weight Management Program (WMP)
Phentermine / Topiramate Extended Release Oral Capsule: Medication for chronic weight management (Rx)
naltrexone/bupropion extended-release: Medication for chronic weight management (Rx)
liraglutide 3.0 mg: Medication for chronic weight management (Rx)
Orlistat: Medication for chronic weight management (Rx)
|
Obesity-centric Approach Without AOM
n=23 Participants
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Weight Management Program (WMP): Weight Management Program (WMP)
|
Usual Care Approach (Comorbidity-centric Approach)
n=24 Participants
Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.
Traditional care: Traditional care
|
|---|---|---|---|
|
Mean Change in Body Weight Between Baseline and 12 Months
|
-8.74 % of body weight
Interval -10.74 to -6.74
|
-6.68 % of body weight
Interval -8.71 to -4.65
|
-4.48 % of body weight
Interval -6.52 to -2.45
|
PRIMARY outcome
Timeframe: 12 MonthsAll relevant time points used in the calculation in the Time Frame between baseline and 12 months. Measured in the mean change of the percentage of glycosylated hemoglobin from baseline to 12 months
Outcome measures
| Measure |
Obesity-centric Approach + AOM
n=24 Participants
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
Weight Management Program (WMP): Weight Management Program (WMP)
Phentermine / Topiramate Extended Release Oral Capsule: Medication for chronic weight management (Rx)
naltrexone/bupropion extended-release: Medication for chronic weight management (Rx)
liraglutide 3.0 mg: Medication for chronic weight management (Rx)
Orlistat: Medication for chronic weight management (Rx)
|
Obesity-centric Approach Without AOM
n=23 Participants
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Weight Management Program (WMP): Weight Management Program (WMP)
|
Usual Care Approach (Comorbidity-centric Approach)
n=23 Participants
Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.
Traditional care: Traditional care
|
|---|---|---|---|
|
Mean Change in A1C
|
-2.18 Percentage of glycosylated hemoglobin
Interval -2.61 to -1.74
|
-2.22 Percentage of glycosylated hemoglobin
Interval -2.65 to -1.79
|
-1.65 Percentage of glycosylated hemoglobin
Interval -2.09 to -1.22
|
Adverse Events
Obesity-centric Approach + AOM
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Obesity-centric Approach Without AOM
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Approach (Comorbidity-centric Approach)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Obesity-centric Approach + AOM
n=24 participants at risk
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
Weight Management Program (WMP): Weight Management Program (WMP)
Phentermine / Topiramate Extended Release Oral Capsule: Medication for chronic weight management (Rx)
naltrexone/bupropion extended-release: Medication for chronic weight management (Rx)
liraglutide 3.0 mg: Medication for chronic weight management (Rx)
Orlistat: Medication for chronic weight management (Rx)
|
Obesity-centric Approach Without AOM
n=23 participants at risk
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Weight Management Program (WMP): Weight Management Program (WMP)
|
Usual Care Approach (Comorbidity-centric Approach)
n=23 participants at risk
Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.
Traditional care: Traditional care
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea, Vomiting, Pain
|
0.00%
0/24 • 1 year
|
4.3%
1/23 • Number of events 1 • 1 year
|
0.00%
0/23 • 1 year
|
Other adverse events
| Measure |
Obesity-centric Approach + AOM
n=24 participants at risk
Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately two years. After discussing with the study doctor, participants will receive one of the following listed 4 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) phentermine/topiramate extended-release, 3) naltrexone/bupropion extended-release and 4) liraglutide 3.0 mg
Weight Management Program (WMP): Weight Management Program (WMP)
Phentermine / Topiramate Extended Release Oral Capsule: Medication for chronic weight management (Rx)
naltrexone/bupropion extended-release: Medication for chronic weight management (Rx)
liraglutide 3.0 mg: Medication for chronic weight management (Rx)
Orlistat: Medication for chronic weight management (Rx)
|
Obesity-centric Approach Without AOM
n=23 participants at risk
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Weight Management Program (WMP): Weight Management Program (WMP)
|
Usual Care Approach (Comorbidity-centric Approach)
n=23 participants at risk
Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.
Traditional care: Traditional care
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Number of events 3 • 1 year
|
0.00%
0/23 • 1 year
|
8.7%
2/23 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place