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

NCT00584389 | Terminated Phase 4

• 2 other identifiers: EC/2006/117/PGMSEudract 2006-006424-18
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Energy expenditure; Fatty acid; Triglyceride

Outcome Measures

Primary Outcomes (1)

• The direct effect of rimonabant on energy expenditure

  12 weeks

Secondary Outcomes (5)

• Whole body fatty acid production and oxidation rate.

  12 weeks

• Triglyceride synthesis and clearance rate.

  12 weeks

• Whole body fat distribution.

  12 weeks

• Adipose tissue and muscle mRNA levels of key regulators of fatty acid metabolism.

  12 weeks

• Insulin sensitivity.

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Rimonabant treatment (20mg/d) for 12 weeks

Drug: rimonabant

2

OTHER

Dietary intervention

Behavioral: Dietary intervention

Interventions

rimonabant DRUG

20mg/d (oral) once daily for 12 weeks

Also known as: Acomplia

1

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.

2

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Caucasian postmenopausal women
• BMI 30-38

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Surrey: lead
• European Foundation for the Study of Diabetes: collaborator
• Royal Surrey County Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 16291982 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.

  PMID: 15836887 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.

  PMID: 16478899 BACKGROUND

• 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.

  PMID: 22445512 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Rimonabant; Diet Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Nutrition Therapy; Therapeutics

Study Officials

• David L Russell-Jones, MBBS,MD,FRCP

  UK National Health Service

  STUDY DIRECTOR

• Margot Umpleby, BA, PhD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: January 2, 2008
• Study Start: July 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2010
• Last Updated: April 19, 2010

Record last verified: 2010-04

Locations

GB (1)