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

20-648

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).

2020-09-01

2022-08-15

2023-06-01

Active (not recruiting)

Early phase I

69

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 69, 'type': 'ACTUAL'}}

2023-04-11