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Comparison of the Effect of Intense-Exercise/Moderate-Calorie, Topiramate-Phentermine and Cognitive Behavioral Therapy on Obesity

NCT01970566 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-01-15

No results posted yet for this study

Summary

Obesity is a prevalent disorder and linked with inflammation, insulin resistance, dyslipidemia, obstructive sleep apnea, atherosclerosis, and associated with significant morbidity and mortality. This randomized clinical trial will compare the effectiveness of Intense Exercise/Moderate Calorie Restriction (IE-MCR), Topiramate-Phentermine (TP) and cognitive behavioral therapy (CBT) on obesity and atherosclerosis in individuals with morbidly obesity. This randomized clinical trial will compare: 1) the change in fat mass and atherosclerosis, 2) the change in psychological and quality-of-life as well as economic burden in response to IE-MCR, TP and CBT, and 3) conduct exploratory mechanistic biomolecular, genetic and therapeutic analyses to develop intervention-specific individualized intervention models to improve management of morbidly obese individuals.

Conditions

Interventions

OTHER

Behavioral and Drug

Topiramate-Phentermine plus cognitive behavioral therapy

OTHER

Behavioral

Intense Exercise/Moderate Calorie Restriction

OTHER

Behavioral and Drug

Topiramate-Phentermine plus cognitive behavioral therapy

OTHER

Behavioral

Intense Exercise/Moderate Calorie Restriction

Sponsors & Collaborators

Principal Investigators

  • Naser Ahmadi, MD MS PhD · Captain James A. Lovell Federal Health Care Center, North Chicago, IL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-08-31
Completion
2017-11-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01970566 on ClinicalTrials.gov