A study investigating rimonabant and diet in overweight subjects
| ISRCTN | ISRCTN00253207 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00253207 |
| Secondary identifying numbers | RGHT000540 |
- Submission date
- 05/06/2008
- Registration date
- 12/09/2008
- Last edited
- 09/01/2018
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Steven Hunter
Scientific
Scientific
The Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Study information
| Study design | Double-blind, randomised, placebo-controlled, single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Rimonabant has beneficial effects on metabolic parameters over and above that explained by weight loss alone. |
| Ethics approval(s) | Office for Research Ethics Committee Northern Ireland (ORECNI). Date of approval: 04/06/2008 (ref: 08/NIR02/31) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/08/2008 |
| Completion date | 01/08/2010 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key inclusion criteria | 1. Both males and females, age >18 years 2. Body mass index (BMI) >27 kg/m^2 |
| Key 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 |
| Date of first enrolment | 01/08/2008 |
| Date of final enrolment | 01/08/2010 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
The Regional Centre for Endocrinology and Diabetes
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
The Royal Hospitals
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom
| Website | http://www.belfasttrust.hscni.net/index.html |
|---|---|
"ROR" |
https://ror.org/02tdmfk69 |
Funders
Funder type
Government
Northern Ireland Research and Development Office (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
09/01/2018: Internal review.
06/07/2016: Study status changed to stopped as it did not start.
29/06/2016: No publications found, verifying study status with principal investigator
