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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
European Foundation for the Study of Diabetes
Royal Surrey County Hospital NHS Foundation Trust
Information provided by:
University of Surrey

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: rimonabant Behavioral: Dietary intervention Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Rimonabant on Energy Expenditure, Fat Metabolism and Body Composition
Study Start Date : July 2007
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: 1
Rimonabant treatment (20mg/d) for 12 weeks
Drug: rimonabant
20mg/d (oral) once daily for 12 weeks
Other Name: Acomplia

Dietary intervention
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.

Primary Outcome Measures :
  1. The direct effect of rimonabant on energy expenditure [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Whole body fatty acid production and oxidation rate. [ Time Frame: 12 weeks ]
  2. Triglyceride synthesis and clearance rate. [ Time Frame: 12 weeks ]
  3. Whole body fat distribution. [ Time Frame: 12 weeks ]
  4. Adipose tissue and muscle mRNA levels of key regulators of fatty acid metabolism. [ Time Frame: 12 weeks ]
  5. Insulin sensitivity. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00584389

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United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
Sponsors and Collaborators
University of Surrey
European Foundation for the Study of Diabetes
Royal Surrey County Hospital NHS Foundation Trust
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Study Director: David L Russell-Jones, MBBS,MD,FRCP UK National Health Service
Principal Investigator: Margot Umpleby, BA, PhD University of Surrey
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor Margot Umpleby, University of Surrey Identifier: NCT00584389    
Other Study ID Numbers: EC/2006/117/PGMS
Eudract 2006-006424-18
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: April 19, 2010
Last Verified: April 2010
Keywords provided by University of Surrey:
Energy expenditure
Fatty acid
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs