EUCTR2007-000775-42-DE进行中（未招募）不适用
Effects of Rimonabant on Liver Fat, Visceral Adipose Tissue Mass and early Markers of CardioDiabetes in obese Subjects with the Metabolic Syndrome – a randomized, double-blind clinical trial
niversity Hospital Tübingen0 个研究点开始时间: 2007年9月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age: 18 - 70 years, inclusive
- •Gender: male, female
- •BMI: 27- 45
- •Metabolic syndrome according to the ATP III criteria (any 3 of the following):
- •Abdominal obesity: waist circumference > 102 cm (men), > 88 cm (women)
- •Triglyzeride 150 mg/dl
- •HDL < 40 mg/dl (men), < 50 mg/dl (women)
- •Blood pressure 130/ 85 mmHg
- •Fasting glucose 110 mg/dl
- •Or impaired fasting glucose 5.6 mmol/l and 7.0 mmol/l
- •Or impaired glucose tolerance : 2-h-glucose (75g OGTT) 7.8 mmol/l and 11.1 mmol/l
- •Stable weight (+ 5 kg) in the last 6 months
- •No lifestyle intervention study in the last 6 months
- •Willing and able to complete screening and study procedures, as described in the protocol
- •Signed written informed consent to participate in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •General health problems (e.g. cancer, cardiovascular events in the past 12 months)
- •Significant findings indicating: cardiovascular, endocrine, pulmonary, neurologic, psychiatric, gastrointestinal, hepatic, hematologic, renal, or dermatologic disease
- •Any of the following blood examination results:
- •Positive hepatitis-B-surface-antigen
- •Positive hepatitis-C antibody
- •Positive HIV-antibodies
- •Abnormal thyrotropin level
- •GPT, GOT > 2.5 times the upper limit of the normal range
- •Haemoglobin levels < 11 g/dl
- •Neutrophil levels < 1500 /mm3
- •Platelet levels < 100.000/ mm3
- •Creatinine level > 150 ?mol/l
- •Any positive history of marijuana or hashish use, no matter how long ago or a positive drug test for marijuana or hashish
- •Acutal misuse of other drugs
- •Severe depression (requiring hospitalization or indicated by a suicidal attempt)
- •Mild or severe depression according to the depression questionnaire (MDI) at screening
- •Antidepressive pharmacological treatment
- •Treatment for epilepsy and eating disorder or a malignant disease
- •Diabetes mellitus (type 1 or 2)
- •Pharmacological treatment of dyslipidemia within 6 weeks before screening
- •Systolic blood pressure > 165 mmHg
- •Diastolic blood pressure > 105 mmHg
- •Hypersensivity to the active substance or to any of the exipients (see SPC appendix 17.1)
- •Exclusion criterias for MRT-, 1HMRS- examinations: non-compliance, pace maker, cochlea implant, nerve stimulators, magnetic vascular clips, metallic heart valve or other contraindications for MRT-, 1HMRS- examinations
- •Patients with lactose intolerance, rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose
- •Regular use potent CYP3A4 inhibitiors: ketoconazole, itraconazole, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir (protease inhibitors), delavirdin, erythromycin, telithromycin, clarithromycin, nefazodone, cimetidine, fluoxetine, fluvoxamine, paroxetine, sertaline, naringenine (grape fruit juice), verapamile
- •Potent CYPA3-Inducers: rifampicin, phenytoin, phenobarbital, carbamazepine, St John’s wort
- •Any Medication containing cannabis
研究者
相似试验
已完成
3 期
VIsceral Fat Reduction Assessed by CT-scan On RImonabAntMetabolic SyndromeNCT00299325Sanofi254
进行中（未招募）
不适用
Effects of rimonabant (Acomplia) on obesity in adults with Prader-Willi SyndromeObese adults with Prader Willi SyndromeMedDRA version: 9.1Level: LLTClassification code 10036476Term: Prader-Willi syndromeMedDRA version: 9.1Level: LLTClassification code 10029883Term: ObesityEUCTR2007-006305-25-SEKarolinska University Hospital
进行中（未招募）
1 期
The effect of semaglutide therapy on hepatic fat content and on the acute response of liver fat to high-fat loadMedDRA version: 20.0Level: PTClassification code: 10029883Term: Obesity Class: 100000004861ObesityCTIS2023-504988-16-00Institut Klinicke A Experimentalni Mediciny16
进行中（未招募）
1 期
Effect of Liraglutide on fatty liver content evaluated by 1H-spectroscopy and lipoprotein kinetic, in patients with type 2 diabetesEUCTR2012-000375-16-FRCHU Dijon120
已完成
不适用
CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USEISRCTN63367873niversity Maastricht (UM) (The Netherlands)600