Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes

Not Applicable

• Conditions: Taurine; Diabetes; Lower Extremity Artery Disease
• Interventions: Drug: Taurine; Drug: Placebo

• Registration Number: NCT03410537
• Lead Sponsor: Third Military Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-12-28
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-24
• Last Update Submitted: 2018-01-24
• Study First Posted: 2018-01-25
• Last Update Posted: 2018-01-25
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taurine Supplementation	Taurine	Taurine 2.4mg/d for 12 weeks
Placebo	Placebo	Placebo 2.4mg/d for 12 weeks

Primary Outcome Measures

Name	Time	Method
Ankle-brachial index	Baseline, 12weeks(End of Trial)	Changes of ankle-brachial index after 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Pulse wave velocity(PWV)	Baseline, 12weeks(End of Trial)
Fasting plasma glucose	Baseline, 12weeks(End of Trial)
24-hours mean blood pressure.	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)

Trial Locations

Locations (1)

The third hospital affiliated to the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China