Clinical trial NCT03410537: Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
Official title: A Randomized, Double-blind, Placebo Controlled Clinical Trial Comparing Effects of Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Taurine
Diabetes
Lower Extremity Artery Disease
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ankle-brachial index
timeFrame: Baseline, 12weeks(End of Trial)
Secondary outcomes:
measure: 24-hours mean blood pressure.
timeFrame: Baseline, 12weeks(End of Trial)
measure: Pulse wave velocity(PWV)
timeFrame: Baseline, 12weeks(End of Trial)
measure: Fasting plasma glucose
timeFrame: Baseline, 12weeks(End of Trial)
measure: HbA1c
timeFrame: Baseline, 12weeks(End of Trial)
measure: Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L)
timeFrame: Baseline, 12weeks(End of Trial)
measure: Carotid intima-media thickness(IMT)
timeFrame: Baseline, 12weeks(End of Trial)
measure: Body mass index(BMI)
timeFrame: Baseline, 12weeks(End of Trial)
measure: Fasting serum insulin
timeFrame: Baseline, 12weeks(End of Trial)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The third hospital affiliated to the Third Military Medical University
state: Chongqing
Study officials:
References: