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Information provided by:
The Cleveland Clinic
Last updated:
11/04/2022
Trial identifier:
NCT04531176
DisclaimerBrief summary:
This is a pragmatic, 24 month, single-center, randomized, open-label, parallel-group trial comparing an obesity-centric approach with a medically-supervised and comprehensive weight loss program (Cleveland Clinic's Endocrinology and Metabolism Institute's Integrated Weight Management Program) augmented by AOMs, vs. an obesity-centric approach with a medically-supervised and comprehensive weight loss program without AOMs, vs. the current usual care approach to general health management. Informed consent will be obtained. IRB approval of the study will be obtained. 300 subjects (employees or spouses covered by our EHP) will be randomized 1:1:1 to receive either an obesity-centric approach with AOM therapy (N=100), an obesity-centric approach without AOM therapy (N=100), or the current usual care approach to general health management (N=100).
Detailed Description:
Glossary term:
An ObEsity-centric Approach With and Without Anti-obesity Medications ComPared to the Usual-care ApprOach to Management of Patients With Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial
Glossary term:
Interventional
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69
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Phase 4
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20-648
Glossary term:
Other: Weight Management Program (WMP)
Other: Traditional care
Drug: Phentermine / Topiramate Extended Release Oral Capsule
Drug: naltrexone/bupropion extended-release
Drug: liraglutide 3.0 mg
Drug: Orlistat
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Sep 01, 2020
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Aug 15, 2022
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Mar 01, 2023
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Aug 10, 2020
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Aug 27, 2020
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Aug 28, 2020
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Nov 03, 2022
Glossary term:
Nov 04, 2022
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Cleveland, Ohio 44195
United States
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. For general information about clinical research, read Guides to Clinical Trials.
Glossary term:
18 Years - 75 Years
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No
Glossary term:
All
Inclusion Criteria:
Exclusion Criteria:
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Treatment
Randomized
Parallel Assignment
3
Glossary term:
Glossary term:
Experimental: 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
Experimental: 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
Other: Weight Management Program (WMP)
Weight Management Program (WMP)
Other: Weight Management Program (WMP)
Weight Management Program (WMP)
Drug: Phentermine / Topiramate Extended Release Oral Capsule
Medication for chronic weight management (Rx)
Drug: Phentermine / Topiramate Extended Release Oral Capsule
Medication for chronic weight management (Rx)
Drug: naltrexone/bupropion extended-release
Medication for chronic weight management (Rx)
Drug: naltrexone/bupropion extended-release
Medication for chronic weight management (Rx)
Drug: liraglutide 3.0 mg
Medication for chronic weight management (Rx)
Drug: liraglutide 3.0 mg
Medication for chronic weight management (Rx)
Drug: Orlistat
Medication for chronic weight management (Rx)
Drug: Orlistat
Medication for chronic weight management (Rx)
Experimental: Obesity-centric approach without AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Experimental: Obesity-centric approach without AOM
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.
Other: Weight Management Program (WMP)
Weight Management Program (WMP)
Other: Weight Management Program (WMP)
Weight Management Program (WMP)
Active Comparator: 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.
Active Comparator: 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.
Other: Traditional care
Traditional care
Other: Traditional care
Traditional care
Glossary term:
Change in body weight
Measured in percentage
12 Months
Change in A1C
Measured in percentage
12 Months
Change in body weight
Measured in percentage
12 Months
Change in A1C
Measured in percentage
12 Months
Glossary term:
Change in body weight
Measured in percentage
24 Months
Change in A1C
Measured in percentage
24 Months
Efficacy of medication
Measured in percentage of weight loss
24 Months
Participants achieving 5% ore more reduction in body weight
Percentage of participants achieving weight loss at 6, 12 and 24 months
24 Months
Mean weight loss at 6 months
Change from baseline in body weight at 6 months
24 Months
Participants achieving A1c less than 7.0%
Percentage of participants achieving target of A1C less than 7.0% at 6, 12 and 24 months
24 Months
Mean A1C at 6 months
Change from baseline in A1C at 6 months
24 Months
Mean Serum LDL, HDL
Change from baseline in serum LDL, HDL at 6, 12 and 24 months
24 Months
Mean Serum triglycerides
Change from baseline in serum triglycerides at 6, 12 and 24 months
24 Months
Participants achieving blood pressure less than 140/90 mmHg
Percentage of participants achieving target less than 140/90 mmHg at 6, 12 and 24 months
24 Months
Mean Quality of Life (QOL) questionnaire
Mean change from baseline in survey scores at 6, 12, 24 months
24 Months
Mean total cost of care
Determined per claims data from our EHP at 12 and 24 months
24 Months
Change in body weight
Measured in percentage
24 Months
Change in A1C
Measured in percentage
24 Months
Efficacy of medication
Measured in percentage of weight loss
24 Months
Participants achieving 5% ore more reduction in body weight
Percentage of participants achieving weight loss at 6, 12 and 24 months
24 Months
Mean weight loss at 6 months
Change from baseline in body weight at 6 months
24 Months
Participants achieving A1c less than 7.0%
Percentage of participants achieving target of A1C less than 7.0% at 6, 12 and 24 months
24 Months
Mean A1C at 6 months
Change from baseline in A1C at 6 months
24 Months
Mean Serum LDL, HDL
Change from baseline in serum LDL, HDL at 6, 12 and 24 months
24 Months
Mean Serum triglycerides
Change from baseline in serum triglycerides at 6, 12 and 24 months
24 Months
Participants achieving blood pressure less than 140/90 mmHg
Percentage of participants achieving target less than 140/90 mmHg at 6, 12 and 24 months
24 Months
Mean Quality of Life (QOL) questionnaire
Mean change from baseline in survey scores at 6, 12, 24 months
24 Months
Mean total cost of care
Determined per claims data from our EHP at 12 and 24 months
24 Months
The Sponsor of a study is the organization or person that is conducting the study. They may provide resources needed to do the investigation.
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