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Trial record 18 of 32 for:    Hydrogen Sulfide

Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes

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ClinicalTrials.gov Identifier: NCT03410537
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, 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.

Condition or disease Intervention/treatment Phase
Taurine Diabetes Lower Extremity Artery Disease Drug: Taurine Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled Clinical Trial Comparing Effects of Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Taurine

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



Primary Outcome Measures :
  1. Ankle-brachial index [ Time Frame: Baseline, 12weeks(End of Trial) ]
    Changes of ankle-brachial index after 12 weeks.


Secondary Outcome Measures :
  1. 24-hours mean blood pressure. [ Time Frame: Baseline, 12weeks(End of Trial) ]
  2. Pulse wave velocity(PWV) [ Time Frame: Baseline, 12weeks(End of Trial) ]
  3. Fasting plasma glucose [ Time Frame: Baseline, 12weeks(End of Trial) ]
  4. HbA1c [ Time Frame: Baseline, 12weeks(End of Trial) ]
  5. Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L) [ Time Frame: Baseline, 12weeks(End of Trial) ]
  6. Carotid intima-media thickness(IMT) [ Time Frame: Baseline, 12weeks(End of Trial) ]
  7. Body mass index(BMI) [ Time Frame: Baseline, 12weeks(End of Trial) ]
  8. Fasting serum insulin [ Time Frame: Baseline, 12weeks(End of Trial) ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410537


Contacts
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Contact: Yan Zhencheng, MD 86-023-68757882 zhenchengyan@sina.com
Contact: Zhu Zhiming, MD 86-23-68767881 zhuzm@yahoo.com

Locations
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China, Chongqing
The third hospital affiliated to the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Yan Zhencheng, MD    86-023-68757882    zhenchengyan@sina.com   
Sponsors and Collaborators
Third Military Medical University

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Responsible Party: Zhiming Zhu, MD,PhD,Director, Third Military Medical University
ClinicalTrials.gov Identifier: NCT03410537     History of Changes
Other Study ID Numbers: TSLEVD
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases