Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03410537
• Other study ID #: TSLEVD
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2017
• Last updated: January 24, 2018
• Start date: January 2017
• Est. completion date: June 2018

Study information

• Verified date: January 2018
• Source: Third Military Medical University
• Contact: Yan Zhencheng, MD
• Phone: 86-023-68757882
• Email: zhenchengyan[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Lower Extremity Artery Disease
• Taurine
• Vascular Diseases

Intervention

Drug:
• Taurine

• Placebo

Locations

Country	Name	City	State
China	The third hospital affiliated to the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle-brachial index	Changes of ankle-brachial index after 12 weeks.	Baseline, 12weeks(End of Trial)
Secondary	24-hours mean blood pressure.		Baseline, 12weeks(End of Trial)
Secondary	Pulse wave velocity(PWV)		Baseline, 12weeks(End of Trial)
Secondary	Fasting plasma glucose		Baseline, 12weeks(End of Trial)
Secondary	HbA1c		Baseline, 12weeks(End of Trial)
Secondary	Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L)		Baseline, 12weeks(End of Trial)
Secondary	Carotid intima-media thickness(IMT)		Baseline, 12weeks(End of Trial)
Secondary	Body mass index(BMI)		Baseline, 12weeks(End of Trial)
Secondary	Fasting serum insulin		Baseline, 12weeks(End of Trial)