A Randomized, Double-blind, Placebo Controlled Clinical Trial Comparing Effects of Taurine Supplementation on Cognitive Function 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
- Changes of cognitive function assessed by cognitive function scale after 12 weeks.
研究概览
简要总结
Diabetes has become important risk factors for threatening human life and health. Studies have shown that chronic hyperglycemia lead to microvascular brain injury. The more common types of dementia are Alzheimer's disease (AD). Cognitive dysfunction is a precursor to Alzheimer's disease. Mild cognitive impairment (MCI) is a cognitive impairment between normal aging and dementia, mainly manifested as memory impairment, especially episode memory defects, but also named obstacles, but the overall cognitive function is normal, daily life ability is normal. Studies have shown that middle-aged diabetic patients' cognitive ability will decline by about 19% in 20 years compared to people without 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 themicroangiopathy 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
- •Type 2 diabetes
排除标准
- •Type2 diabetes with acute diabetic complications.
- •Type1 diabetes.
- •History of depression, schizophrenia or dementia.
- •History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
- •History of parkinson's diseases, head injury,toxic encephacopathy,epilepsy.
- •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
Placebo
2.4mg/d for 12 weeks
干预措施: Placebo (Drug)
Taurine
2.4mg/d for 12 weeks
干预措施: Taurine (Drug)
结局指标
主要结局
Changes of cognitive function assessed by cognitive function scale after 12 weeks.
时间窗: Baseline, 12weeks(End of Trial)
次要结局
- Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L)(Baseline, 12weeks(End of Trial))
- 24-hours mean blood pressure.(Baseline, 12weeks(End of Trial))
- Fasting plasma glucose(Baseline, 12weeks(End of Trial))
- HbA1c(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