EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial
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).
Timeline
- Start
- 2020-09-01
- Primary completion
- 2022-08-15
- Completion
- 2023-08-04
Outcome
Mixed primary results
Stopped: “After an unplanned yet IRB approved interim analysis, it was found that there was not a significant difference between the 3 arms of the study. The study was closed due to futility. All Patients are off study and this study will not resume.”
registry MEAN Obesity-centric Approach + AOM: -8.74 (-10.74 to -6.74) % of body weight NCT04531176 ↗
registry analysis (non-inferiority test); Obesity-centric Approach + AOM vs Obesity-centric Approach Without AOM vs Usual Care Approach (Comorbidity-centric Approach); p = 0.004; NCT04531176 ↗
registry MEAN Obesity-centric Approach + AOM: -2.18 (-2.61 to -1.74) Percentage of glycosylated hemoglobin NCT04531176 ↗
registry analysis (non-inferiority test); Obesity-centric Approach + AOM vs Obesity-centric Approach Without AOM vs Usual Care Approach (Comorbidity-centric Approach); p = 0.05; NCT04531176 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Liraglutide | Peptide | 3 mg | — |
| Subject | Orlistat | Small molecule | — | — |
| Subject | naltrexone/bupropion | Unknown | — | — |
| Subject | phentermine/topiramate | Unknown | — | Oral |