Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes; Taurine; Lower Extremity Artery Disease
• Intervention / Treatment: Drug: Placebo; Drug: Taurine

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • The third hospital affiliated to the Third Military Medical University
      • Contact: Yan Zhencheng, MD; Phone Number: 86-023-68757882; Email: zhenchengyan@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taurine Supplementation; Taurine 2.4mg/d for 12 weeks	Drug: Taurine
Placebo Comparator: Placebo; Placebo 2.4mg/d for 12 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle-brachial index	Changes of ankle-brachial index after 12 weeks.	Baseline, 12weeks(End of Trial)

Secondary Outcome Measures

Outcome Measure	Time Frame
24-hours mean blood pressure.	Baseline, 12weeks(End of Trial)
Fasting plasma glucose	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)
Pulse wave velocity(PWV)	Baseline, 12weeks(End of Trial)
Fasting serum insulin	Baseline, 12weeks(End of Trial)

Collaborators and Investigators

• Sponsor: Third Military Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Vascular Diseases
• Other Study ID Numbers: TSLEVD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No