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ObesityPhase 4NCT00584389

The Effect of Rimonabant on Energy Expenditure, Fat Metabolism and Body Composition

A Phase 4 study testing rimonabant and Dietary intervention in people with Obesity, run by University of Surrey at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will determine in obese subjects the direct effects of the weight loss drug rimonabant (ie independent of weight loss) on energy expenditure, fat metabolism and and body fat distribution. We hypothesise that rimonabant will increase energy expenditure. Read more about this study

Who is it for?
Ages 50 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
rimonabant and Dietary intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2007to May 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy Caucasian postmenopausal women
  • BMI 30-38

Who cannot join

  • Not currently weight-stable
  • Diagnosed with diabetes
  • Cardiovascular disease
  • Endocrine disease
  • Hepatic and renal disorders
  • Neurological/psychological illness/history of depression
Show all 10Show fewer
  • Previous surgical procedures for weight loss
  • Medications known to alter body weight or appetite
  • β-blockers, fibrates and metformin
  • Severe under-reporting of food intake based on a 4 day food diary

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

Other trials in United Kingdom

About this study

This study will determine in obese subjects the direct effects of the weight loss drug rimonabant (ie independent of weight loss) on energy expenditure, fat metabolism and and body fat distribution. We hypothesise that rimonabant will increase energy expenditure. The fuel for the increased energy expenditure will come from fat. As a result of burning more fat there will be a decrease in fat in blood and an improvement in the body's response to insulin.

Read the detailed description

In obese subjects (BMI 33-38kg/m2) completing 12 months of treatment with the CB1 antagonist rimonabant (SR141716) there was an average weight loss from baseline of approximately 8.5 kg. These studies also showed the weight loss was accompanied by a decrease in plasma triglyceride (TG), an increase in HDL cholesterol and an improvement in insulin sensitivity measured by HOMA-IR. When adjusted for weight loss 50% of the improvements in TG, HDL cholesterol, and insulin sensitivity was not attributable to weight loss. This suggests that rimonabant has direct effects on fat metabolism.

This study will investigate the direct effects of rimonabant (ie independent of weight loss) in a 2 group randomised study. One group will receive rimonabant for 12 weeks and the other group will have a dietary intervention to match the weight loss in the rimonabant group. Measurements of energy expenditure (using indirect calorimetry and Actiheart monitors),fatty acid and triglyceride metabolism (using stable isotope techniques) and body fat distribution (by magnetic resonance imaging) will be made before and after the intervention. To determine the possible mechanisms of the changes in metabolism, gene expression of key regulators of fatty acid metabolism in adipose and muscle tissue and circulating levels of adipokines will be measured.

Conditions
Obesity
Being tested
rimonabant, Dietary intervention
Keywords
Obesity, Energy expenditure, Fatty acid, Triglyceride
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rimonabantDrug

    Also called Acomplia

    20mg/d (oral) once daily for 12 weeks

  • Dietary interventionBehavioural

    Dietary intervention to match weight loss in group 1. The energy prescription will be based on the estimate of the energy deficit estimated from the weight loss in group one. For example a weight loss of 5kg over 12 weeks equates to an approximate energy deficit of 30,000 kcal or a daily energy reduction of approximately 357 kcal. If this is achieved in group 1 the daily energy target for subjects in group 2 will be daily energy expenditure minus 357 kcal.For the subjects randomised to the dietary intervention group there will be a delay until group 1 subjects have completed the study.

Study groups in NCT00584389
Study groupRoleWhat they receive
1ExperimentalRimonabant treatment (20mg/d) for 12 weeks
Receives: Drug: rimonabant
2OtherDietary intervention
Receives: Behavioral: Dietary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The direct effect of rimonabant on energy expenditure

    Measured: 12 weeks

Secondary outcomes (5)

  1. Whole body fatty acid production and oxidation rate.

    Measured: 12 weeks

  2. Triglyceride synthesis and clearance rate.

    Measured: 12 weeks

  3. Whole body fat distribution.

    Measured: 12 weeks

  4. Adipose tissue and muscle mRNA levels of key regulators of fatty acid metabolism.

    Measured: 12 weeks

  5. Insulin sensitivity.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2008 (estimated)
  2. Study startJul 2007
  3. Primary completionApr 2009 (estimated)
  4. Study completionMay 2010 (estimated)

Why it stopped: Suspension of licence for rimonabant by European Medicines Agency

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00584389
Sponsor's protocol ID
EC/2006/117/PGMS
Other IDs
Eudract 2006-006424-18
Status last verified
Apr 2010
First submitted
11 Dec 2007
Last updated
19 Apr 2010
Results posted
No
Data monitoring committee
No

Publications

  • Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34. doi: 10.1056/NEJMoa044537.

    PubMed 16291982

  • Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rossner S; RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant on weight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005 Apr 16-22;365(9468):1389-97. doi: 10.1016/S0140-6736(05)66374-X.

    PubMed 15836887

  • Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J; RIO-North America Study Group. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA. 2006 Feb 15;295(7):761-75. doi: 10.1001/jama.295.7.761.

    PubMed 16478899

  • Backhouse K, Sarac I, Shojaee-Moradie F, Stolinski M, Robertson MD, Frost GS, Bell JD, Thomas EL, Wright J, Russell-Jones D, Umpleby AM. Fatty acid flux and oxidation are increased by rimonabant in obese women. Metabolism. 2012 Sep;61(9):1220-3. doi: 10.1016/j.metabol.2012.02.012. Epub 2012 Mar 24.

    PubMed 22445512

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rimonabant and Dietary intervention in people with Obesity, run by University of Surrey at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Suspension of licence for rimonabant by European Medicines Agency). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The direct effect of rimonabant on energy expenditure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00584389, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2010.

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