Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
Primary Purpose
Taurine, Diabetes, Lower Extremity Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Taurine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Taurine
Eligibility Criteria
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.
Sites / Locations
- The third hospital affiliated to the Third Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Taurine Supplementation
Placebo
Arm Description
Taurine 2.4mg/d for 12 weeks
Placebo 2.4mg/d for 12 weeks
Outcomes
Primary Outcome Measures
Ankle-brachial index
Changes of ankle-brachial index after 12 weeks.
Secondary Outcome Measures
24-hours mean blood pressure.
Pulse wave velocity(PWV)
Fasting plasma glucose
HbA1c
Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L)
Carotid intima-media thickness(IMT)
Body mass index(BMI)
Fasting serum insulin
Full Information
NCT ID
NCT03410537
First Posted
December 28, 2017
Last Updated
January 24, 2018
Sponsor
Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03410537
Brief Title
Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
Official Title
A Randomized, Double-blind, Placebo Controlled Clinical Trial Comparing Effects of Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Taurine, Diabetes, Lower Extremity Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Taurine Supplementation
Arm Type
Experimental
Arm Description
Taurine 2.4mg/d for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 2.4mg/d for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Taurine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Ankle-brachial index
Description
Changes of ankle-brachial index after 12 weeks.
Time Frame
Baseline, 12weeks(End of Trial)
Secondary Outcome Measure Information:
Title
24-hours mean blood pressure.
Time Frame
Baseline, 12weeks(End of Trial)
Title
Pulse wave velocity(PWV)
Time Frame
Baseline, 12weeks(End of Trial)
Title
Fasting plasma glucose
Time Frame
Baseline, 12weeks(End of Trial)
Title
HbA1c
Time Frame
Baseline, 12weeks(End of Trial)
Title
Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L)
Time Frame
Baseline, 12weeks(End of Trial)
Title
Carotid intima-media thickness(IMT)
Time Frame
Baseline, 12weeks(End of Trial)
Title
Body mass index(BMI)
Time Frame
Baseline, 12weeks(End of Trial)
Title
Fasting serum insulin
Time Frame
Baseline, 12weeks(End of Trial)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhencheng, MD
Phone
86-023-68757882
Email
zhenchengyan@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu Zhiming, MD
Phone
86-23-68767881
Email
zhuzm@yahoo.com
Facility Information:
Facility Name
The third hospital affiliated to the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhencheng, MD
Phone
86-023-68757882
Email
zhenchengyan@sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
We'll reach out to this number within 24 hrs