Obesity MedDRA version: 8.1 Level: LLT Classification code 10029883 Term: Obesity
Conditions
Interventions
Trade Name: Acomplia
Pharmaceutical Form: Film-coated tablet
Sponsors
University of Surrey
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in obese subjects the effect of rimonabant on 1. Total energy expenditure 2. The rate of whole body fatty acid production, oxidation and uptake in muscle 3. Whole body triglyceride synthesis rate and clearance rate and muscle uptake;Secondary Objective: To investigate the direct effect of rimonabant on 1. Adipose tissue and muscle mRNA levels of key regulators of fatty acid metabolism 2. Whole body fat distribution, liver fat and muscle fat 3. Insulin sensitivity;Primary end point(s): Total energy expenditure | — |
Countries
United Kingdom
Outcome results
None listed