- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03410537
Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
January 24, 2018 updated by: Zhiming Zhu, Third Military Medical University
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yan Zhencheng, MD
- Phone Number: 86-023-68757882
- Email: zhenchengyan@sina.com
Study Contact Backup
- Name: Zhu Zhiming, MD
- Phone Number: 86-23-68767881
- Email: zhuzm@yahoo.com
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- Male or female, age between 18-80 years old
- Type 2 diabetes
Exclusion Criteria:
- Type2 diabetes with acute diabetic complications.
- Type1 diabetes.
- History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
- Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
- Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
- Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
- Fertile woman without contraceptives.
- Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
- Allergic to or have contraindication to the intervention drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Taurine Supplementation
Taurine 2.4mg/d for 12 weeks
|
|
Placebo Comparator: Placebo
Placebo 2.4mg/d for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle-brachial index
Time Frame: Baseline, 12weeks(End of Trial)
|
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.
Time Frame: Baseline, 12weeks(End of Trial)
|
Baseline, 12weeks(End of Trial)
|
Fasting plasma glucose
Time Frame: Baseline, 12weeks(End of Trial)
|
Baseline, 12weeks(End of Trial)
|
HbA1c
Time Frame: Baseline, 12weeks(End of Trial)
|
Baseline, 12weeks(End of Trial)
|
Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L)
Time Frame: Baseline, 12weeks(End of Trial)
|
Baseline, 12weeks(End of Trial)
|
Carotid intima-media thickness(IMT)
Time Frame: Baseline, 12weeks(End of Trial)
|
Baseline, 12weeks(End of Trial)
|
Body mass index(BMI)
Time Frame: Baseline, 12weeks(End of Trial)
|
Baseline, 12weeks(End of Trial)
|
Pulse wave velocity(PWV)
Time Frame: Baseline, 12weeks(End of Trial)
|
Baseline, 12weeks(End of Trial)
|
Fasting serum insulin
Time Frame: Baseline, 12weeks(End of Trial)
|
Baseline, 12weeks(End of Trial)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- TSLEVD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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