Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes

Third Military Medical University

Status: Unknown

Conditions: Taurine; Lower Extremity Artery Disease; Diabetes

Treatments: Drug: Placebo; Drug: Taurine

Study type: Interventional

Funder types: Other

Identifiers

NCT03410537

TSLEVD

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age between 18-80 years old
2. Type 2 diabetes

Exclusion criteria

1. Type2 diabetes with acute diabetic complications.
2. Type1 diabetes.
3. History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
4. Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
5. Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
6. Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
7. Fertile woman without contraceptives.
8. Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
9. Allergic to or have contraindication to the intervention drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Taurine Supplementation

Experimental group

Description:

Taurine 2.4mg/d for 12 weeks

Treatment:

Drug: Taurine

Placebo

Placebo Comparator group

Description:

Placebo 2.4mg/d for 12 weeks

Treatment:

Drug: Placebo