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Status unknownNCT03410537Updated Jan 25, 2018

Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes

An interventional study of Taurine and Placebo in Taurine, Diabetes and Lower Extremity Artery Disease, sponsored by Third Military Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-25.

Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Taurine
  • Diabetes
  • Lower Extremity Artery Disease
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Type2 diabetes with acute diabetic complications.
  2. Type1 diabetes.
  3. History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
  4. Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
  5. Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
  6. Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
  7. Fertile woman without contraceptives.
  8. Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
  9. Allergic to or have contraindication to the intervention drugs.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Taurine Supplementation

    Taurine 2.4mg/d for 12 weeks

    Drug: Taurine

  • Placebo comparator
    Placebo

    Placebo 2.4mg/d for 12 weeks

    Drug: Placebo

Interventions

  • DrugTaurine
  • DrugPlacebo
05

What researchers measure

Primary outcomes

  1. Ankle-brachial index

    Changes of ankle-brachial index after 12 weeks.

    Time frame: Baseline, 12weeks(End of Trial)

Secondary outcomes

  1. 24-hours mean blood pressure.

    Time frame: Baseline, 12weeks(End of Trial)

  2. Pulse wave velocity(PWV)

    Time frame: Baseline, 12weeks(End of Trial)

  3. Fasting plasma glucose

    Time frame: Baseline, 12weeks(End of Trial)

  4. HbA1c

    Time frame: Baseline, 12weeks(End of Trial)

  5. Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L)

    Time frame: Baseline, 12weeks(End of Trial)

  6. Carotid intima-media thickness(IMT)

    Time frame: Baseline, 12weeks(End of Trial)

  7. Body mass index(BMI)

    Time frame: Baseline, 12weeks(End of Trial)

  8. Fasting serum insulin

    Time frame: Baseline, 12weeks(End of Trial)

06

Study locations

1 of 1 sites recruiting
  • The third hospital affiliated to the Third Military Medical University
    Chongqing, Chongqing 400042, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03410537
Lead sponsor
Third Military Medical University
Responsible party
Zhiming Zhu (MD,PhD,Director, Third Military Medical University) — Principal investigator
First posted
Jan 25, 2018
Start date
Jan 2017
Primary completion
Jun 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Jan 25, 2018

Study contacts

Yan Zhencheng, MD
Contact
zhenchengyan@sina.com
86-023-68757882
Zhu Zhiming, MD
Contact
zhuzm@yahoo.com
86-23-68767881
View the source record on ClinicalTrials.gov ↗

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