Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes

NCT ID: NCT03410537

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-06-30

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.

Conditions

Taurine; Diabetes; Lower Extremity Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Taurine Supplementation

Taurine 2.4mg/d for 12 weeks

Group Type: EXPERIMENTAL

Taurine

Intervention Type: DRUG

Placebo

Placebo 2.4mg/d for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Taurine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhiming Zhu

MD,PhD,Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Zhencheng, MD

Role: CONTACT

zhenchengyan@sina.com

86-023-68757882

Zhu Zhiming, MD

Role: CONTACT

zhuzm@yahoo.com

86-23-68767881

Facility Contacts

Yan Zhencheng, MD

Role: primary

zhenchengyan@sina.com

86-023-68757882

Other Identifiers

TSLEVD

Identifier Type: -

Identifier Source: org_study_id