EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Bupropion; Liraglutide; Naltrexone; Orlistat; Phentermine; Topiramate

Criteria

Inclusion Criteria:

1. Gender: men and women

2. Ethnicity: all ethnic groups

3. Age: ≥18, < 75 years

4. Diagnosis of T2D -A1C within the last 90 days must be >7.5%

5. Obesity, BMI ≥30

6. An Employee, or the significant other of an employee, that is covered by the Cleveland Clinic Employee Health Plan

Exclusion Criteria:

1. Type 1 diabetes or known latent autoimmune diabetes of adulthood (LADA)

2. Glomerular Filtration Rate <30 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI)

3. Current glucocorticoid therapy

4. Currently or within the past 3 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss

5. Any condition, unwillingness or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol

6. Mental incapacity or language barrier

7. Pregnancy or plans to become pregnant within the next 2 years

8. Personal or family history of medullary thyroid carcinoma

9. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2

10. History of acute pancreatitis, severe liver disease (Cirrhosis), or severe disease of digestive tract

11. History of congestive heart failure

12. History of bariatric or metabolic surgery/procedure

13. Visit with an endocrinologist within the past 1 year

14. Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight Management Program