Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT000540
Study information
Scientific title
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
Acronym
Study hypothesis
Rimonabant has beneficial effects on metabolic parameters over and above that explained by weight loss alone.
Ethics approval
Office for Research Ethics Committee Northern Ireland (ORECNI). Date of approval: 04/06/2008 (ref: 08/NIR02/31)
Study design
Double-blind, randomised, placebo-controlled, single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Overweight and obese subjects at risk of type 2 diabetes
Intervention
Subjects will be randomised to one of two arms. Study arms are identical in their strict low fat weight reduction diet but will differ in medication. Subjects on one arm will take 20 mg rimonabant (oral) daily and those on the other arm will take placebo.
Duration of interventions: 8 weeks
Intervention type
Drug
Phase
Not Specified
Drug names
Rimonabant
Primary outcome measure
The following will be assessed at baseline and 8 weeks (end of interventions):
1. Insulin resistance, assessed using the euglycaemic hyperinsulinaemic glucose clamp technique
2. Weight
Secondary outcome measures
The following will be assessed at baseline and 8 weeks (end of interventions):
1. Meal tolerance tests
2. Glycaemic control
3. Vascular compliance
4. Body composition
5. Plasma lipids
6. Adipokines
7. Fat biopsies
Overall trial start date
01/08/2008
Overall trial end date
01/08/2010
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Both males and females, age >18 years
2. Body mass index (BMI) >27 kg/m^2
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
1. Pregnant women/ breastfeeding mothers
2. Women of childbearing age unwilling to use appropriate contraception
3. Subjects with history of depression or anxiety
4. Subjects with history of significant cardiac, renal or hepatic dysfunction
5. Subjects concurrently on weight loss medication
Recruitment start date
01/08/2008
Recruitment end date
01/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Regional Centre for Endocrinology and Diabetes
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
The Royal Hospitals
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northern Ireland Research and Development Office (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list