TTA in Treatment of Diabetes and Dyslipidemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Plasma lipids
研究概览
简要总结
The aim of the study is to evaluate the short-term effects of tetradecylthioacetic acid (TTA) on plasma lipids and glucose in male patients with type 2 diabetes mellitus and dyslipidemia
详细描述
The tight linkage of obesity, insulin resistance (and frank diabetes), dyslipidemia, and hypertension has been widely observed and has been named syndrome X, or the metabolic syndrome. For many years metformin has been the only drug in clinical use with effects on insulin resistance. Recently, agonists of the peroxisome proliferator-activated receptors (PPARs) have been introduced in the treatment of type 2 diabetes. The different PPARs seem to be activated by a wide range of lipids and lipid mediators, including fatty acids. 2-tetradecylthioacetic acid (TTA) is a modified fatty acid with high affinity for the PPARgamma receptor. In animal models of obesity-related insulin resistance (obese Zucker rats and dietary manipulated Wistar rats), TTA has an insulin sensitizing effect by enhancing the insulin mediated uptake of glucose in peripheral tissues. TTA treatment promotes fatty acid catabolism in experimental animals and this could casually be linked to the improved glucose tolerance.
The protocol for the present study describes a safety assessment and therapeutic exploratory evaluation of TTA in a small subset of male type 2 diabetes patients for 4 weeks. The primary safety parameters will include general physical observational parameters, liver function test and hematological parameters. To goal is to assess the efficacy of TTA on selected metabolic parameters including fasting blood glucose and insulin, fasting plasma lipids, antioxidant status, and fibrinolytic parameters, weight, BMI and blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus with HbA1c 8.0-12.0%,
- •fasting S-triacylglycerol 2.0-10.0 mmol/L,
- •body mass index 25-40 kg/m2 and/or waist/hip ratio > 0.90.
排除标准
- •fasting total cholesterol >10 mmol/L,
- •blood pressure 170/110 mmHg
- •other significant disease
- •Use of any corticosteroid, anticoagulant or lipid-lowering drug 2 weeks prior to inclusion.
研究组 & 干预措施
Single group
Single group all treated similarly, outcome evaluated as changes within individuals during intervention
干预措施: Tetradecylthioacetic acid (TTA) (Drug)
结局指标
主要结局
Plasma lipids
时间窗: -28 days, baseline, 14 and 28 days of TTA
次要结局
- Plasma glucose(-28 days, baseline, 14 and 28 days of TTA)
- Safety blood parameters(-28 days, baseline, 14 and 28 days of TTA)