Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/06/2008
Date assigned
12/09/2008
Last edited
06/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Steven Hunter

ORCID ID

Contact details

The Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

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 measures

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

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

http://www.belfasttrust.hscni.net/index.html

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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