The Effect of Rimonabant on Energy Expenditure, Fat Metabolism and Body Composition
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Surrey
-
Guildford、Surrey、イギリス、GU2 7XX
- Royal Surrey County Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:1
Rimonabant treatment (20mg/d) for 12 weeks
|
20mg/d (oral) once daily for 12 weeks
他の名前:
|
他の:2
Dietary intervention
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
The direct effect of rimonabant on energy expenditure
時間枠:12 weeks
|
12 weeks
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Whole body fatty acid production and oxidation rate.
時間枠:12 weeks
|
12 weeks
|
Triglyceride synthesis and clearance rate.
時間枠:12 weeks
|
12 weeks
|
Whole body fat distribution.
時間枠:12 weeks
|
12 weeks
|
Adipose tissue and muscle mRNA levels of key regulators of fatty acid metabolism.
時間枠:12 weeks
|
12 weeks
|
Insulin sensitivity.
時間枠:12 weeks
|
12 weeks
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:David L Russell-Jones, MBBS,MD,FRCP、UK National Health Service
- 主任研究者:Margot Umpleby, BA, PhD、University of Surrey
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EC/2006/117/PGMS
- Eudract 2006-006424-18
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。