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The Effect of Rimonabant on Energy Expenditure, Fat Metabolism and Body Composition

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ClinicalTrials.gov Identifier: NCT00584389
Recruitment Status : Terminated (Suspension of licence for rimonabant by European Medicines Agency)
First Posted : January 2, 2008
Last Update Posted : April 19, 2010
Sponsor:
Collaborators:
European Foundation for the Study of Diabetes
Royal Surrey County Hospital NHS Foundation Trust
Information provided by:
University of Surrey

Tracking Information
First Submitted Date  ICMJE December 11, 2007
First Posted Date  ICMJE January 2, 2008
Last Update Posted Date April 19, 2010
Study Start Date  ICMJE July 2007
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2007)
The direct effect of rimonabant on energy expenditure [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2007)
  • Whole body fatty acid production and oxidation rate. [ Time Frame: 12 weeks ]
  • Triglyceride synthesis and clearance rate. [ Time Frame: 12 weeks ]
  • Whole body fat distribution. [ Time Frame: 12 weeks ]
  • Adipose tissue and muscle mRNA levels of key regulators of fatty acid metabolism. [ Time Frame: 12 weeks ]
  • Insulin sensitivity. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Rimonabant on Energy Expenditure, Fat Metabolism and Body Composition
Official Title  ICMJE The Effect of Rimonabant on Energy Expenditure, Fat Metabolism and Body Composition
Brief Summary This study will determine in obese subjects the direct effects of the weight loss drug rimonabant (ie independent of weight loss) on energy expenditure, fat metabolism and and body fat distribution. We hypothesise that rimonabant will increase energy expenditure. The fuel for the increased energy expenditure will come from fat. As a result of burning more fat there will be a decrease in fat in blood and an improvement in the body's response to insulin.
Detailed Description

In obese subjects (BMI 33-38kg/m2) completing 12 months of treatment with the CB1 antagonist rimonabant (SR141716) there was an average weight loss from baseline of approximately 8.5 kg. These studies also showed the weight loss was accompanied by a decrease in plasma triglyceride (TG), an increase in HDL cholesterol and an improvement in insulin sensitivity measured by HOMA-IR. When adjusted for weight loss 50% of the improvements in TG, HDL cholesterol, and insulin sensitivity was not attributable to weight loss. This suggests that rimonabant has direct effects on fat metabolism.

This study will investigate the direct effects of rimonabant (ie independent of weight loss) in a 2 group randomised study. One group will receive rimonabant for 12 weeks and the other group will have a dietary intervention to match the weight loss in the rimonabant group. Measurements of energy expenditure (using indirect calorimetry and Actiheart monitors),fatty acid and triglyceride metabolism (using stable isotope techniques) and body fat distribution (by magnetic resonance imaging) will be made before and after the intervention. To determine the possible mechanisms of the changes in metabolism, gene expression of key regulators of fatty acid metabolism in adipose and muscle tissue and circulating levels of adipokines will be measured.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: rimonabant
    20mg/d (oral) once daily for 12 weeks
    Other Name: Acomplia
  • Behavioral: Dietary intervention
    Dietary intervention to match weight loss in group 1. The energy prescription will be based on the estimate of the energy deficit estimated from the weight loss in group one. For example a weight loss of 5kg over 12 weeks equates to an approximate energy deficit of 30,000 kcal or a daily energy reduction of approximately 357 kcal. If this is achieved in group 1 the daily energy target for subjects in group 2 will be daily energy expenditure minus 357 kcal.For the subjects randomised to the dietary intervention group there will be a delay until group 1 subjects have completed the study.
Study Arms  ICMJE
  • Experimental: 1
    Rimonabant treatment (20mg/d) for 12 weeks
    Intervention: Drug: rimonabant
  • 2
    Dietary intervention
    Intervention: Behavioral: Dietary intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 16, 2010)
14
Original Estimated Enrollment  ICMJE
 (submitted: December 31, 2007)
32
Estimated Study Completion Date  ICMJE May 2010
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Caucasian postmenopausal women
  • BMI 30-38

Exclusion Criteria:

  • Not currently weight-stable
  • Diagnosed with diabetes
  • Cardiovascular disease
  • Endocrine disease
  • Hepatic and renal disorders
  • Neurological/psychological illness/history of depression
  • Previous surgical procedures for weight loss
  • Medications known to alter body weight or appetite
  • β-blockers, fibrates and metformin
  • Severe under-reporting of food intake based on a 4 day food diary
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00584389
Other Study ID Numbers  ICMJE EC/2006/117/PGMS
Eudract 2006-006424-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Margot Umpleby, University of Surrey
Study Sponsor  ICMJE University of Surrey
Collaborators  ICMJE
  • European Foundation for the Study of Diabetes
  • Royal Surrey County Hospital NHS Foundation Trust
Investigators  ICMJE
Study Director: David L Russell-Jones, MBBS,MD,FRCP UK National Health Service
Principal Investigator: Margot Umpleby, BA, PhD University of Surrey
PRS Account University of Surrey
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP