Taurine, Diabetes, Lower Extremity Artery Disease
Conditions
Brief summary
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.
Interventions
DRUGTaurine
DRUGPlacebo
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankle-brachial index | Baseline, 12weeks(End of Trial) | Changes of ankle-brachial index after 12 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Pulse wave velocity(PWV) | Baseline, 12weeks(End of Trial) |
| Fasting plasma glucose | Baseline, 12weeks(End of Trial) |
| HbA1c | Baseline, 12weeks(End of Trial) |
| 24-hours mean blood pressure. | 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) |
| Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L) | Baseline, 12weeks(End of Trial) |
Countries
China
Contacts
Primary ContactYan Zhencheng, MD
Backup ContactZhu Zhiming, MD
Outcome results
None listed