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

Phase 1

• Conditions: 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.
• Interventions: Drug: Taurine

• Registration Number: NCT01226537
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Status Verified: 2012-11
• Study Start: 2012-11
• Last Update Submitted: 2012-11-07
• Last Update Posted: 2012-11-09
• Primary Completion: 2013-11
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 -

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes type 2 taurine	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.
Diabetes type 2 placebo	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.
Diabetes mellitus type 1 placebo	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.
Diabetes Mellitus type 1 taurine	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.

Primary Outcome Measures

Name	Time	Method
Fasting glucose 2) HbA1c 3) Lipid profile 4) Taurine 5) Insulin 6) Urine Micro albumin 7) Eye test	9 months	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