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

January 14, 2014 updated by: US Department of Veterans Affairs

Effect of Intense-Exercise/Moderate-Calorie vs Topiramate-Phentermine on Obesity

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Background. Obesity is prevalent disorder; up to 60% of US population that is associated with significant morbidity and mortality through inflammation, insulin resistance, dyslipidemia, obstructive sleep apnea, and atherosclerosis. The economic burden of obesity-related illnesses is substantial, with estimates ranging from 2% to 7% of the total US health care expenditures and billions of dollars in direct and indirect costs to society. This randomized clinical trial will compared the effectiveness of Intense Exercise/Moderate Calorie Restriction (IE-MCR), Topiramate-Phentermine (TP) and cognitive behavioral therapy (CBT) on obesity and atherosclerosis in morbidly obesity individuals (body mass index(BMI)>40 kg/m2 or BMI>35 kg/m2 with associated comorbidities) with diabetes mellitus (DM).

Importance/Significance. There is a cumulative increase in the rate of obesity, up to 60% of the US population. This randomized clinical trial will compare: 1) the change in fat mass and atherosclerosis and, 2) the change in psychological status and quality-of-life as well as economic burden in response to IE-MCR, TP and CBT in morbidly obese individuals with DM. Furthermore, 3) exploratory analyses evaluating the different underling adipocyte molecular mechanisms will be conducted. This will investigate the underlying genomic determinants and characterizes the management of obesity by comparing biologic, clinical phenotype, and cost effectiveness of these two interventions. These aims will provide fundamental information to assess the beneficial effects within and across interventions on obesity and atherosclerosis management which will help provide individualized intervention models to improve management of morbidly obese individuals Method. A significant difference in reduction of fat mass, carotid/coronary atherosclerosis, improve in psychological, quality of life and economic burden measures, as well as exploratory mechanism of action across IE-MCR, TP and CBT methods, are hypothesized. Over a 5 year period, 60 morbidly obese individuals with diabetes mellitus aged 18 or older and free of clinical cardiovascular disease will be recruited from the Obesity Clinic of the Greater Los Angeles VA Health Care System, University of California Los Angeles and Captain Lovell Federal Healthcare Center. Eligible subjects will be randomized to either of intense exercise/moderate calorie restriction, Topiramate-Phentermine or cognitive behavioral therapy (20 in each group) and receive these intervention for 12-months. Intense exercise/moderate calorie restriction group will receive lectures on exercise and general dietary measures including calorie counting. They will prepare their own food, with protein:carbohydrate:fat ratio of 30:45:25 and over 70% of their resting daily energy expenditure (RDEE), and completed daily food and exercise journals. They will exercise ~2.5 hours/day, about 1/4 supervised, for a year. Topiramate-Phentermine group will receive full dose of TP (15/92mg) pills daily for a period of 1-year. Furthermore, CBT group as well as IE-MCR and TP will receive weekly cognitive behavior therapy for a year. All subjects will undergo carotid ultrasound; coronary computed tomography angiography, bioelectric impedance spectroscopy, dual-energy X-ray absorptiometry, ambulatory calorimetry, serial home resting metabolic rate serial home (RMR),sleep apnea assessment and abdominal fat pad fine-needle aspiration biopsy (FNAB), as well as measurement of oxidative stress/inflammatory/metabolic biomarkers at baseline and at 1-year follow-up. Quality of life, psychological health and economic burden will be assessed using standardized questionnaires. Participants will complete quarterly trial visits for physical exam, compliance to intervention as well as ascertainment of adverse effects.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • North Chicago, Illinois, United States, 60064
        • Captain James A. Lovell Federal Health Care Center, North Chicago, IL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IE-MCR
Intense Exercise/Moderate Calorie Restriction
Other: Behavioral
Intense Exercise/Moderate Calorie Restriction
Other Names:
  • IE-MCR
Active Comparator: TP-CBT
Topiramate-Phentermine plus cognitive behavioral therapy
Other: Behavioral and Drug
Topiramate-Phentermine plus cognitive behavioral therapy
Other Names:
  • TP-CBT
Active Comparator: CBT
cognitive behavioral therapy
Other: Behavioral
Intense Exercise/Moderate Calorie Restriction
Other Names:
  • IE-MCR
Other: Behavioral and Drug
Topiramate-Phentermine plus cognitive behavioral therapy
Other Names:
  • TP-CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the rate of change in fat mass in intense exercise/moderate diet restriction, topiramate-phentermine and cognitive behavior therapy
Time Frame: 12 month and 24 month Follow Ups
compare the change in extracellular/total body water, body fat/lean mass and metabolically active adipose tissue in response to IE-MCR vs. TP-CBT.
12 month and 24 month Follow Ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the rate of atherosclerotic burden in intense exercise/moderate diet restriction, topiramate-phentermine and cognitive behavior therapy
Time Frame: 12 month and 24 month Follow Ups
Compare the change in carotid intima media thickness, coronary artery distensibility index and plaque volume in response to IE-MCR,TP or CBT.
12 month and 24 month Follow Ups
Compare the change in neuropsychiatric status in response to intense exercise/moderate diet restriction, topiramate-phentermine and cognitive behavioral therapy
Time Frame: 12 month and 24 month Follow Ups
compare the change in cognition, anxiety, depression and vitality in response to IE-MCR, TP and CBT.
12 month and 24 month Follow Ups
Comparison the rate of and atherosclerotic burden in intense exercise/moderate diet restriction, topiramate-phentermine and cognitive behavior therapy
Time Frame: 12 month and 24 month Follow Ups
Compare the change in carotid intima media thickness, coronary artery distensibility index and plaque volume in response to IE-MCR,TP or CBT.
12 month and 24 month Follow Ups
Compare the change in quality-of-life in response to intense exercise/moderate diet restriction, topiramate-phentermine and cognitive behavioral therapy
Time Frame: 12 month and 24 month Follow Ups
Compare the change in satisfaction, well-Being and quality of life in response to IE-MCR, TP and CBT
12 month and 24 month Follow Ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-001-12F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Behavioral

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe