EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

NCT04531176 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 20-648
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (2)

• Mean Change in Body Weight Between Baseline and 12 Months

  All relevant time points used in the calculation in the Time Frame between baseline and 12 months. Measured in the mean Change in body weight between baseline and 12 months measured in percentage (%) of body weight loss

  12 Months

• Mean Change in A1C

  All relevant time points used in the calculation in the Time Frame between baseline and 12 months. Measured in the mean change of the percentage of glycosylated hemoglobin from baseline to 12 months

  12 Months

Study Arms (3)

Obesity-centric approach + AOM

EXPERIMENTAL

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); Drug: Phentermine / Topiramate Extended Release Oral Capsule; Drug: naltrexone/bupropion extended-release; Drug: liraglutide 3.0 mg; Drug: Orlistat

Obesity-centric approach without AOM

EXPERIMENTAL

Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately two years.

Other: Weight Management Program (WMP)

Usual care approach (Comorbidity-centric approach)

ACTIVE COMPARATOR

Participants will receive the traditional usual care/standard of care approach to T2D, hypertension, hypercholesterolemia management for approximately two years.

Other: Traditional care

Interventions

Weight Management Program (WMP) OTHER

Weight Management Program (WMP)

Obesity-centric approach + AOM; Obesity-centric approach without AOM

Traditional care OTHER

Traditional care

Usual care approach (Comorbidity-centric approach)

Phentermine / Topiramate Extended Release Oral Capsule DRUG

Medication for chronic weight management (Rx)

Obesity-centric approach + AOM

naltrexone/bupropion extended-release DRUG

Medication for chronic weight management (Rx)

Obesity-centric approach + AOM

liraglutide 3.0 mg DRUG

Medication for chronic weight management (Rx)

Obesity-centric approach + AOM

Orlistat DRUG

Medication for chronic weight management (Rx)

Obesity-centric approach + AOM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender: men and women
• Ethnicity: all ethnic groups
• Age: ≥18, \< 75 years
• Diagnosis of T2D -A1C within the last 90 days must be \>7.5%
• Obesity, BMI ≥30
• An Employee, or the significant other of an employee, that is covered by the Cleveland Clinic Employee Health Plan

You may not qualify if:

• Type 1 diabetes or known latent autoimmune diabetes of adulthood (LADA)
• Glomerular Filtration Rate \<30 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI)
• Current glucocorticoid therapy
• Currently or within the past 3 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss
• Mental incapacity or language barrier
• Pregnancy or plans to become pregnant within the next 2 years
• Personal or family history of medullary thyroid carcinoma
• Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
• History of acute pancreatitis, severe liver disease (Cirrhosis), or severe disease of digestive tract
• History of congestive heart failure
• History of bariatric or metabolic surgery/procedure
• Visit with an endocrinologist within the past 1 year
• Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight Management Program

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Phentermine; Naltrexone; Liraglutide; Orlistat

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Lactones

Results Point of Contact

• Title: Kim Jenkins
• Organization: The Cleveland Clinic Foundation

jenkink@ccf.org

216-445-4791

Study Officials

• Bartolome Burguera

  Institute Chairman

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 28, 2020
• Study Start: September 1, 2020
• Primary Completion: August 15, 2022
• Study Completion: August 4, 2023
• Last Updated: September 19, 2024
• Results First Posted: July 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)