THE EFFECT OF RIMONABANT ON ENERGY EXPENDITURE, FATTY ACID METABOLISM, TRIACYLGLYCEROL METABOLISM AND BODY FAT DISTRIBUTION - Metabolic effects of Rimonabant

Conditions: Obesity
MedDRA version: 8.1Level: LLTClassification code 10029883Term: Obesity

Registration Number: EUCTR2006-006424-18-GB

Lead Sponsor: niversity of Surrey

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Obese (BMI 30-38)
Caucasian
Post-menopausal female subjects
Age 50-65
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded if they are not currently weight-stable, diagnosed with diabetes or suffering from either cardiovascular or endocrine disease, hepatic and renal disorders, substantial neurological or psychological illness, history of depression and previous surgical procedures for weight loss. Exclusion criteria will also include the prescribed use of any medications known to alter body weight or appetite, B-blockers, statins, fibrates and metformin and severe under-reporting of food intake based on a 4 day food diary.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate in obese subjects the effect of rimonabant on<br>1. Total energy expenditure<br>2. The rate of whole body fatty acid production, oxidation and uptake in muscle<br>3. Whole body triglyceride synthesis rate and clearance rate and muscle uptake;Secondary Objective: To investigate the direct effect of rimonabant on<br>1. Adipose tissue and muscle mRNA levels of key regulators of fatty acid metabolism<br>2. Whole body fat distribution, liver fat and muscle fat<br>3. Insulin sensitivity;Primary end point(s): Total energy expenditure<br>

Secondary Outcome Measures