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EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

NCT04531176 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-09-19

Study results available
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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).

Conditions

Interventions

OTHER

Weight Management Program (WMP)

Weight Management Program (WMP)

OTHER

Traditional care

Traditional care

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

liraglutide 3.0 mg

Medication for chronic weight management (Rx)

DRUG

Orlistat

Medication for chronic weight management (Rx)

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Bartolome Burguera · Institute Chairman

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-08-15
Completion
2023-08-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04531176 on ClinicalTrials.gov