Effect of Diacerein on Insulin Secretion in Patients With Type 2 Diabetes Mellitus and Overweight or Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Fasting insulin concentration
研究概览
简要总结
Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα) inhibition with diacerein administration on insulin secretion and metabolic control of drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.
Hypothesis. Diacerein administration improves insulin secretion and metabolic control of drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.
Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial. Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements: A metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as well as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin secretion and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for the first 15 days and twice daily for 45 additional days or placebo. Statistical analyses: Wilcoxon signed rank and Mann-Whitney U test.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting glucose levels between 7.0 and 11.1 mmol/L
- •A1C levels between 7 and 9%
- •Same residential area and socioeconomic status
- •Excessively sedentary or participated in heavy physical activity
- •Nonsmokers
- •Body weight was stable for at least 3 months before the study
- •Blood pressure was <130/80 mm Hg
排除标准
- •Personal history of hepatic, renal or coronary artery disease
- •Medications known to affect metabolism during the previous 6 months.
研究组 & 干预措施
Diacerein
干预措施: Diacerein (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Fasting insulin concentration
时间窗: 2 mo
Fasting glucose concentration
时间窗: 2 mo
A1C concentration
时间窗: 2 mo
First phase of insulin secretion
时间窗: 2 mo
Late phase of insulin secretion
时间窗: 2 mo
Total insulin secretion concentration
时间窗: 2 mo
次要结局
未报告次要终点