- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03410173
Taurine Supplementation on Cognitive Function in Patients With Diabetes
A Randomized, Double-blind, Placebo Controlled Clinical Trial Comparing Effects of Taurine Supplementation on Cognitive Function in Patients With Diabetes
Diabetes has become important risk factors for threatening human life and health. Studies have shown that chronic hyperglycemia lead to microvascular brain injury. The more common types of dementia are Alzheimer's disease (AD). Cognitive dysfunction is a precursor to Alzheimer's disease. Mild cognitive impairment (MCI) is a cognitive impairment between normal aging and dementia, mainly manifested as memory impairment, especially episode memory defects, but also named obstacles, but the overall cognitive function is normal, daily life ability is normal. Studies have shown that middle-aged diabetic patients' cognitive ability will decline by about 19% in 20 years compared to people without 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 themicroangiopathy and lower extremity arterial occlusive.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetes
Exclusion Criteria:
- Type2 diabetes with acute diabetic complications.
- Type1 diabetes.
- History of depression, schizophrenia or dementia.
- History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
- History of parkinson's diseases, head injury,toxic encephacopathy,epilepsy.
- 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
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
2.4mg/d for 12 weeks
|
|
Placebo Comparator: Placebo
2.4mg/d for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes of cognitive function assessed by cognitive function scale after 12 weeks.
Time Frame: Baseline, 12weeks(End of Trial)
|
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)
|
Fasting serum insulin.
Time Frame: Baseline, 12weeks(End of Trial)
|
Baseline, 12weeks(End of Trial)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TSCFD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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