NCT03410537

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

December 28, 2017

Last Update Submit

January 24, 2018

Conditions

TaurineDiabetesLower Extremity Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Ankle-brachial index

    Changes of ankle-brachial index after 12 weeks.

    Baseline, 12weeks(End of Trial)

Secondary Outcomes (8)

  • 24-hours mean blood pressure.

    Baseline, 12weeks(End of Trial)

  • Pulse wave velocity(PWV)

    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)

  • +3 more secondary outcomes

Study Arms (2)

Taurine Supplementation

EXPERIMENTAL

Taurine 2.4mg/d for 12 weeks

Drug: Taurine

Placebo

PLACEBO COMPARATOR

Placebo 2.4mg/d for 12 weeks

Drug: Placebo

Interventions

TaurineDRUG
Taurine Supplementation
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age between 18-80 years old
  • Type 2 diabetes

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Taurine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Central Study Contacts

Yan Zhencheng, MD

CONTACT

86-023-68757882zhenchengyan@sina.com

Zhu Zhiming, MD

CONTACT

86-23-68767881zhuzm@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)