A study investigating rimonabant versus placebo in conjunction with a strict low-fat weight reduction diet in overweight and obese subjects: effects on glucose and lipid metabolism and cardiovascular risk.

Conditions: This study will investigate subjects who are overweight and obese with Body Mass Index >27kg/m2.
MedDRA version: 9.1Level: LLTClassification code 10022489Term: Insulin resistance

Registration Number: EUCTR2008-001003-38-GB

Lead Sponsor: The Royal Group of Hospitals, Belfast Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- BMI >27kg/m2
- Age >18 years old
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Significant cardiac, renal or hepatic disease
- History of depression or anxiety
- Women of childbearing potential unless on appropriate contraception
- Pregnant women
- Already using pharmacotherapy to induce weight loss

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to assess insulin resistance and weight loss following the 8 week period of rimonabant/placebo and diet.;Secondary Objective: Secondary objectives will include the measurement of glycaemic control, insulin secretion, plasma lipid and adipokines, vascular compliance, body composition and fat biopsy analysis;Primary end point(s): Insulin resistance measured by hyperinsulinaemic euglycaemic glucose clamps (baseline and end).

Secondary Outcome Measures