Effect of Taurine on Glycemic Control in Type I and Type II Diabetic Patients

This study is not yet open for participant recruitment.
Verified November 2012 by Hamad Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01226537
First received: October 21, 2010
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

Diabetes mellitus (DM) and its vascular complications are the one of the most prevalent diseases in the state of Qatar. It is a multifactorial disease associated with the development of retinopathy, nephropathy, neuropathy, cardiomyopathy, and severe vascular dysfunction. The complications of diabetes are caused by either insulin deficiency (type 1 DM) or insulin resistance (type II DM).Unfortunately, effective and sustainable prevention programs of diabetes are limited, and treatment options for type II DM are restricted. Current therapy is based upon control of blood glucose, cholesterol and triglycerides, primarily through insulin replacement in type I diabetes or oral hypoglycemic agents and/or insulin replacement in type II diabetes. New therapies able to prevent vascular complications of diabetes are needed to decrease the occurrence of end organ damage and improve the quality of life of the people. Safe and effective nutritional supplements that could be given along with the regular treatment of the patients that might reduce the need for insulin replacement therapy provide tighter glucose control and protect against oxidative stress and the vascular pathology associated with diabetes mellitus are the need of the hour. Our hypothesis is that supplementation of Taurine in the diets of diabetic patients might reduce the dose or need for insulin replacement therapy and protect them against oxidative stress that is responsible for the complications of diabetes mellitus.


Condition Intervention Phase
it is a Group of Metabolic Diseases in
Which a Person Has High Blood Sugar, Either
Because the Body Does Not Produce Enough Insulin,
or Because Cells do Not Respond to the Insulin That
is Produced.
Drug: Taurine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Taurine on Glycemic Control in Type I and Type II Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Hamad Medical Corporation:

Primary Outcome Measures:
  • Fasting glucose 2) HbA1c 3) Lipid profile 4) Taurine 5) Insulin 6) Urine Micro albumin 7) Eye test [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    500mg Taurine capsules will be given twice per day for 6 months. After the medication, each month the following outcomes will be measured Fasting glucose 2) HbA1c 3) Lipid profile 4) Taurine 5) Insulin 6) Urine Micro albumin


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diabetes Mellitus type 1 taurine
A total of 20 patients with 10 Type I and 10 type II diabetic will be enrolled in the study.After the preliminary examinations, we will categorize 10 Type I and Type II patients into two groups randomly (each group contain 5 patients).500mg Taurine capsules will be given twice per day for 6 months.
Drug: Taurine
500 mg taurine capsules twice per day for 6 months
Placebo Comparator: Diabetes mellitus type 1 placebo
A total of 20 patients with 10 Type I and 10 type II diabetic will be enrolled in the study.After the preliminary examinations, we will categorize 10 Type I and Type II patients into two groups randomly (each group contain 5 patients).500mg Taurine capsules will be given twice per day for 6 months.
Drug: Taurine
500 mg taurine capsules twice per day for 6 months
Active Comparator: Diabetes type 2 taurine
A total of 20 patients with 10 Type I and 10 type II diabetic will be enrolled in the study.After the preliminary examinations, we will categorize 10 Type I and Type II patients into two groups randomly (each group contain 5 patients).500mg Taurine capsules will be given twice per day for 6 months.
Drug: Taurine
500 mg taurine capsules twice per day for 6 months
Placebo Comparator: Diabetes type 2 placebo
A total of 20 patients with 10 Type I and 10 type II diabetic will be enrolled in the study.After the preliminary examinations, we will categorize 10 Type I and Type II patients into two groups randomly (each group contain 5 patients).500mg Taurine capsules will be given twice per day for 6 months.
Drug: Taurine
500 mg taurine capsules twice per day for 6 months

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female
  2. Above 18-65 Years of old
  3. Known diabetic patients with HbA1c>8.0%
  4. People who provide signed informed consent -

Exclusion Criteria:

  • 1. Pregnancy 2. Diabetic patients with HbA1c <8.0 % 3. Recent or prospective surgical interventions 4. Complications of Type I and Type II DM, e.g., Active cardiovascular disease, nephropathy, retinopathy, neuropathy 5. People who do not provide signed informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226537

Contacts
Contact: Shajitha Thekkeveetil, PhD 00974-44395096 sveetil@hmc.org.qa
Contact: Yousef Al Ansari, MD 00974-2112754 yalansari@hmc.org.qa

Sponsors and Collaborators
Hamad Medical Corporation
  More Information

No publications provided

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT01226537     History of Changes
Obsolete Identifiers: NCT01225588
Other Study ID Numbers: NCT01225588
Study First Received: October 21, 2010
Last Updated: November 7, 2012
Health Authority: Supreme Council of Health:

Keywords provided by Hamad Medical Corporation:
Taurine,Diabetes mellitus,oxidative stress,glycemic control

Additional relevant MeSH terms:
Hyperglycemia
Metabolic Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on April 23, 2014