Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo Controlled Clinical Trial Comparing Effects of Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes

Conditions
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Taurine, Diabetes, Lower Extremity Artery Disease

Intervention / Treatment
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* Drug: Taurine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age between 18-80 years old Type 2 diabetes Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taurine Supplementation<br>Taurine 2.4mg/d for 12 weeks | Drug: Taurine<br> <br> |
| Placebo Comparator: Placebo<br>Placebo 2.4mg/d for 12 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle-brachial index | Changes of ankle-brachial index after 12 weeks. | Baseline, 12weeks(End of Trial) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hours mean blood pressure. |  | Baseline, 12weeks(End of Trial) | 
| Pulse wave velocity(PWV) |  | Baseline, 12weeks(End of Trial) | 
| Fasting plasma glucose |  | 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) |