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

Withdrawn before enrolling · Not applicable

Conditions studied: Obesity, Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01970566

Run by

US Department of Veterans Affairs

People needed

0

Starts

2013-11-01

Expected to finish

2017-11-01

Last updated by the study team

2014-01-15

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 20-70 years
• Competent to give informed consent
• Obesity (BMI>40) or BMI>35 kg/m2 with associated co-morbidities
• Diabetes Mellitus Type II

You may not qualify if…

• History of coronary artery disease, myocardial infarction, coronary angioplasty or bypass surgery
• Prior non-cardiac illness with an estimated life expectancy <4 years
• Unable to give informed consent
• Women who are pregnant or lactating
• Prior bariatric surgery or receiving anti-obesity drugs

Where it is running

• Captain James A. Lovell Federal Health Care Center, North Chicago, IL — North Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.