A Randomized, Double-blind, Placebo Controlled Clinical Trial Comparing Effects of Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ankle-brachial index
研究概览
简要总结
Diabetes has become important risk factors for threatening human life and health. Lower extremity arterial occlusive are the common complications of diabetes.Sulfur amino acid is the indispensable amino acid in mammals, and its metabolites include Taurine, Hydrogen sulfide (H2S) and sulfur dioxide (SO2). Taurine was first isolated more than 150 years ago from ox (Taurus) bile. Although the taurine can be synthesized in vivo by cysteine in the presence of cysteine dioxygenase, it is mainly acquired from dietary sources, such as eggs, meat, and seafood. H2S is a biologically relevant mediator and plays potential roles in several physiological processes and disease states in the body. H2S is synthesized from 2 sulfur-containing amino acids, l-cysteine andl-methionine, by the 3 enzymes,cystathionine-γ-lyase (CSE), cystathionine-β-synthetase(CBS), and3-mercaptopyruvate sulfurtransferase (3-MST). Previous studies have demonstrated that Taurine and H2S may play important roles in the development of the microangiopathy and lower extremity arterial occlusive.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age between 18-80 years old
- •Type 2 diabetes
排除标准
- •Type2 diabetes with acute diabetic complications.
- •Type1 diabetes.
- •History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
- •Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
- •Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
- •Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
- •Fertile woman without contraceptives.
- •Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
- •Allergic to or have contraindication to the intervention drugs.
研究组 & 干预措施
Taurine Supplementation
Taurine 2.4mg/d for 12 weeks
干预措施: Taurine (Drug)
Placebo
Placebo 2.4mg/d for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Ankle-brachial index
时间窗: Baseline, 12weeks(End of Trial)
Changes of ankle-brachial index after 12 weeks.
次要结局
- Pulse wave velocity(PWV)(Baseline, 12weeks(End of Trial))
- Fasting plasma glucose(Baseline, 12weeks(End of Trial))
- 24-hours mean blood pressure.(Baseline, 12weeks(End of Trial))
- HbA1c(Baseline, 12weeks(End of Trial))
- Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L)(Baseline, 12weeks(End of Trial))
- Carotid intima-media thickness(IMT)(Baseline, 12weeks(End of Trial))
- Body mass index(BMI)(Baseline, 12weeks(End of Trial))
- Fasting serum insulin(Baseline, 12weeks(End of Trial))
研究者
Zhiming Zhu
MD,PhD,Director
Third Military Medical University