Taurine Supplementation on Cognitive Function in Patients With Diabetes

NCT03410173 | Unknown

• 1 other identifier: TSCFD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Taurine; Cognitive Decline; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Changes of cognitive function assessed by cognitive function scale after 12 weeks.

  Baseline, 12weeks(End of Trial)

Secondary Outcomes (7)

• 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)

Study Arms (2)

Taurine

EXPERIMENTAL

2.4mg/d for 12 weeks

Drug: Taurine

Placebo

PLACEBO COMPARATOR

2.4mg/d for 12 weeks

Drug: Placebo

Interventions

Taurine DRUG

Taurine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Diabetes Mellitus

Interventions

Taurine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Yan Zhencheng, MD

CONTACT

86-023-68757882; zhenchengyan@sina.com

Zhu Zhiming, MD

CONTACT

86-23-68767881; zhuzm@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD,Director

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 25, 2018
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)