A Randomized, Double Blind, Two-arm Placebo Controlled, 12-Month Study of the Effects of Rimonabant 20mg Once Daily on the Amount and the Activity of Visceral Fat in Abdominally Obese Patients With Metabolic Syndrome.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Relative change in visceral fat area assessed by CT scan
研究概览
简要总结
Primary objective:
To assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome
Secondary objectives:
-
To assess the effect of rimonabant over a period of 12 months on:
-
Liver fat content using CT scan (Computed Tomography scan)
-
Anthropometric measures (weight, waist circumference, body composition using Dual Energy X-ray Absorptiometry (DEXA))
-
Lipid, lipoprotein profile
-
Glycemia, insulinemia and HbA1c
-
Adipokines, inflammatory and hemostatic markers
-
To evaluate the percentage of patients with metabolic syndrome at 12 months
-
To evaluate the safety and tolerability of rimonabant in these patients
In four selected US sites the effect of rimonabant at 12 months will be also assessed on:
- Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp).
- Resting metabolic rate and substrate oxidation at rest using indirect calorimetry.
- Adipose tissue histology and expression of genes involved in glucose and lipid metabolism (superficial adipose tissue biopsy).
详细描述
The total duration per patient will be approximately 15 months including a 12-month double-blind treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rimonabant
Rimonabant 20 mg once daily with mild hypocaloric diet
干预措施: Mild hypocaloric diet (Other)
Rimonabant
Rimonabant 20 mg once daily with mild hypocaloric diet
干预措施: Rimonabant (Drug)
Placebo
Placebo (for Rimonabant) once daily with mild hypocaloric diet
干预措施: Placebo (for Rimonabant) (Drug)
Placebo
Placebo (for Rimonabant) once daily with mild hypocaloric diet
干预措施: Mild hypocaloric diet (Other)
结局指标
主要结局
Relative change in visceral fat area assessed by CT scan
时间窗: From baseline to Month 12
次要结局
- Change in anthropometric measures(From baseline to Month 12)
- Change in glucose control parameters(From baseline to Month 12)
- Change in adipokines, inflammatory and hemostatic markers(From baseline to Month 12)
- Absolute change in visceral fat area assessed by CT scan(From baseline to Month 12)
- Change in Liver fat content measured using CT scan(From baseline to Month 12)
- Change in specific lipid parameters(From baseline to Month 12)
- Percentages of patients with a metabolic syndrome(At 12 months)