TaurineNCT03410537
Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
A study testing Taurine in people with Taurine and Diabetes, run by Third Military Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Taurine, Diabetes, Lower Extremity Artery Disease
- What is being tested?
- Taurine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age between 18-80 years old
- Type 2 diabetes
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Yan Zhencheng, MD, 86-023-68757882, zhenchengyan@sina.com
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Clinical Trial Comparing Effects of Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
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.
- Conditions
- Taurine, Diabetes, Lower Extremity Artery Disease
- Being tested
- Taurine, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Taurine Supplementation | Experimental | Taurine 2.4mg/d for 12 weeks Receives: Drug: Taurine |
| Placebo | Placebo comparator | Placebo 2.4mg/d for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle-brachial index
Changes of ankle-brachial index after 12 weeks.
Measured: Baseline, 12weeks(End of Trial)
Secondary outcomes (8)
24-hours mean blood pressure.
Measured: Baseline, 12weeks(End of Trial)
Pulse wave velocity(PWV)
Measured: Baseline, 12weeks(End of Trial)
Fasting plasma glucose
Measured: Baseline, 12weeks(End of Trial)
HbA1c
Measured: Baseline, 12weeks(End of Trial)
Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L)
Measured: Baseline, 12weeks(End of Trial)
Carotid intima-media thickness(IMT)
Measured: Baseline, 12weeks(End of Trial)
Body mass index(BMI)
Measured: Baseline, 12weeks(End of Trial)
Fasting serum insulin
Measured: Baseline, 12weeks(End of Trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study startJan 2017
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TaurineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410537
- Sponsor's protocol ID
- TSLEVD
- Status last verified
- Jan 2018
- First submitted
- 28 Dec 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Clinical Trial Comparing Effects of Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT03410537
- Acronym / sponsor ID
- TSLEVD
- Conditions
- Taurine, Diabetes, Lower Extremity Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taurine Supplementation | Experimental | Drug: TaurineTaurine 2.4mg/d for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 2.4mg/d for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, age between 18-80 years old
- Type 2 diabetes
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taurine | Drug | Taurine Supplementation |
| Placebo | Drug | Placebo |
Primary outcome
Ankle-brachial index
Time frame: Baseline, 12weeks(End of Trial)
Changes of ankle-brachial index after 12 weeks.
8 secondary outcomes
24-hours mean blood pressure.
Time frame: Baseline, 12weeks(End of Trial)
Pulse wave velocity(PWV)
Time frame: Baseline, 12weeks(End of Trial)
Fasting plasma glucose
Time frame: Baseline, 12weeks(End of Trial)
HbA1c
Time frame: Baseline, 12weeks(End of Trial)
Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L)
Time frame: Baseline, 12weeks(End of Trial)
Carotid intima-media thickness(IMT)
Time frame: Baseline, 12weeks(End of Trial)
Body mass index(BMI)
Time frame: Baseline, 12weeks(End of Trial)
Fasting serum insulin
Time frame: Baseline, 12weeks(End of Trial)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Taurine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taurine in people with Taurine and Diabetes, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhencheng, MD (86-023-68757882, zhenchengyan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle-brachial index (time frame: Baseline, 12weeks(End of Trial)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.