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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

October 21, 2010
November 7, 2012
November 2012
November 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01226537 on ClinicalTrials.gov Archive Site
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Effect of Taurine on Glycemic Control in Type I and Type II Diabetic Patients
Effect of Taurine on Glycemic Control in Type I and Type II Diabetic Patients

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • 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
500 mg taurine capsules twice per day for 6 months
  • 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.
    Intervention: Drug: Taurine
  • 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.
    Intervention: Drug: Taurine
  • 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.
    Intervention: Drug: Taurine
  • 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.
    Intervention: Drug: Taurine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
December 2014
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Shajitha Thekkeveetil, PhD 00974-44395096 sveetil@hmc.org.qa
Contact: Yousef Al Ansari, MD 00974-2112754 yalansari@hmc.org.qa
Not Provided
 
NCT01226537
NCT01225588
Yes
Hamad Medical Corporation
Hamad Medical Corporation
Not Provided
Not Provided
Hamad Medical Corporation
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP