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

NCT00584389 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2010-04-19

No results posted yet for this study

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

Interventions

DRUG

rimonabant

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

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.

Sponsors & Collaborators

  • European Foundation for the Study of Diabetes

    collaborator OTHER

  • Royal Surrey County Hospital NHS Foundation Trust

    collaborator OTHER

  • University of Surrey

    lead OTHER

Principal Investigators

  • David L Russell-Jones, MBBS,MD,FRCP · UK National Health Service

  • Margot Umpleby, BA, PhD · University of Surrey

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-04-30
Completion
2010-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00584389 on ClinicalTrials.gov