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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract 2006-006424-18 |
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Suspension of licence for rimonabant by European Medicines Agency
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| Name | Class |
|---|---|
| European Foundation for the Study of Diabetes | OTHER |
| Royal Surrey County Hospital NHS Foundation Trust | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Rimonabant treatment (20mg/d) for 12 weeks |
|
| 2 | Other | Dietary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rimonabant | Drug | 20mg/d (oral) once daily for 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The direct effect of rimonabant on energy expenditure | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Whole body fatty acid production and oxidation rate. | 12 weeks | |
| Triglyceride synthesis and clearance rate. | 12 weeks | |
| Whole body fat distribution. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L Russell-Jones, MBBS,MD,FRCP | UK National Health Service | Study Director |
| Margot Umpleby, BA, PhD | University of Surrey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Surrey County Hospital | Guildford | Surrey | GU2 7XX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16291982 | Background | Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34. doi: 10.1056/NEJMoa044537. | |
| 15836887 | Background | Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rossner S; RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005 Apr 16-22;365(9468):1389-97. doi: 10.1016/S0140-6736(05)66374-X. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 11, 2025 | |
| Reset | Mar 4, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 11, 2025 | Mar 4, 2025 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077285 | Rimonabant |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dietary intervention | Behavioral | 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. |
|
| 12 weeks |
| Adipose tissue and muscle mRNA levels of key regulators of fatty acid metabolism. | 12 weeks |
| Insulin sensitivity. | 12 weeks |
| 16478899 | Background | Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J; RIO-North America Study Group. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA. 2006 Feb 15;295(7):761-75. doi: 10.1001/jama.295.7.761. |
| 22445512 | Derived | Backhouse K, Sarac I, Shojaee-Moradie F, Stolinski M, Robertson MD, Frost GS, Bell JD, Thomas EL, Wright J, Russell-Jones D, Umpleby AM. Fatty acid flux and oxidation are increased by rimonabant in obese women. Metabolism. 2012 Sep;61(9):1220-3. doi: 10.1016/j.metabol.2012.02.012. Epub 2012 Mar 24. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |