Study Stopped
The project was not announced to the field and it was not funded.
Comparison of the Effect of Intense-Exercise/Moderate-Calorie, Topiramate-Phentermine and Cognitive Behavioral Therapy on Obesity
Effect of Intense-Exercise/Moderate-Calorie vs Topiramate-Phentermine on Obesity
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2013
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2013
CompletedFirst Posted
Study publicly available on registry
October 28, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJanuary 15, 2014
January 1, 2014
1.7 years
August 28, 2013
January 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare the rate of change in fat mass in intense exercise/moderate diet restriction, topiramate-phentermine and cognitive behavior therapy
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 Outcomes (4)
Compare the rate of atherosclerotic burden in intense exercise/moderate diet restriction, topiramate-phentermine and cognitive behavior therapy
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
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
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
12 month and 24 month Follow Ups
Study Arms (3)
IE-MCR
EXPERIMENTALIntense Exercise/Moderate Calorie Restriction
TP-CBT
ACTIVE COMPARATORTopiramate-Phentermine plus cognitive behavioral therapy
CBT
ACTIVE COMPARATORcognitive behavioral therapy
Interventions
Topiramate-Phentermine plus cognitive behavioral therapy
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Captain James A. Lovell Federal Health Care Center, North Chicago, IL
North Chicago, Illinois, 60064, United States
Related Publications (2)
Ahmadi N, Tsimikas S, Hajsadeghi F, Saeed A, Nabavi V, Bevinal MA, Kadakia J, Flores F, Ebrahimi R, Budoff MJ. Relation of oxidative biomarkers, vascular dysfunction, and progression of coronary artery calcium. Am J Cardiol. 2010 Feb 15;105(4):459-66. doi: 10.1016/j.amjcard.2009.09.052.
PMID: 20152239BACKGROUNDAhmadi N, Eshaghian S, Huizenga R, Sosnin K, Ebrahimi R, Siegel R. Effects of intense exercise and moderate caloric restriction on cardiovascular risk factors and inflammation. Am J Med. 2011 Oct;124(10):978-82. doi: 10.1016/j.amjmed.2011.02.032. Epub 2011 Jul 27.
PMID: 21798505RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naser Ahmadi, MD MS PhD
Captain James A. Lovell Federal Health Care Center, North Chicago, IL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2013
First Posted
October 28, 2013
Study Start
November 1, 2013
Primary Completion
August 1, 2015
Study Completion
November 1, 2017
Last Updated
January 15, 2014
Record last verified: 2014-01