- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00584389
The Effect of Rimonabant on Energy Expenditure, Fat Metabolism and Body Composition
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Surrey
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Guildford, Surrey, 영국, GU2 7XX
- Royal Surrey County Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy Caucasian postmenopausal women
- BMI 30-38
Exclusion Criteria:
- Not currently weight-stable
- Diagnosed with diabetes
- Cardiovascular disease
- Endocrine disease
- Hepatic and renal disorders
- Neurological/psychological illness/history of depression
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 1
Rimonabant treatment (20mg/d) for 12 weeks
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20mg/d (oral) once daily for 12 weeks
다른 이름들:
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다른: 2
Dietary intervention
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
The direct effect of rimonabant on energy expenditure
기간: 12 weeks
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12 weeks
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Whole body fatty acid production and oxidation rate.
기간: 12 weeks
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12 weeks
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Triglyceride synthesis and clearance rate.
기간: 12 weeks
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12 weeks
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Whole body fat distribution.
기간: 12 weeks
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12 weeks
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Adipose tissue and muscle mRNA levels of key regulators of fatty acid metabolism.
기간: 12 weeks
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12 weeks
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Insulin sensitivity.
기간: 12 weeks
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12 weeks
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공동 작업자 및 조사자
수사관
- 연구 책임자: David L Russell-Jones, MBBS,MD,FRCP, UK National Health Service
- 수석 연구원: Margot Umpleby, BA, PhD, University of Surrey
간행물 및 유용한 링크
일반 간행물
- 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.
- 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. Erratum In: Lancet. 2005 Jul 30-Aug 5;366(9483):370.
- 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. Erratum In: JAMA. 2006 Mar 15;295(11):1252.
- 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. Erratum In: Metabolism. 2014 Apr;63(4):e7.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EC/2006/117/PGMS
- Eudract 2006-006424-18
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