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.

Study Overview

• Status: Unknown
• 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.
• Intervention / Treatment: Drug: Taurine

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shajitha Thekkeveetil, PhD; Phone Number: 00974-44395096; Email: sveetil@hmc.org.qa
• Study Contact Backup: Name: Yousef Al Ansari, MD; Phone Number: 00974-2112754; Email: yalansari@hmc.org.qa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose 2) HbA1c 3) Lipid profile 4) Taurine 5) Insulin 6) Urine Micro albumin 7) Eye test	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	9 months

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): November 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: October 21, 2010
• First Submitted That Met QC Criteria: October 21, 2010
• First Posted (Estimate): October 22, 2010

Study Record Updates

• Last Update Posted (Estimate): November 9, 2012
• Last Update Submitted That Met QC Criteria: November 7, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Taurine,Diabetes mellitus,oxidative stress,glycemic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Hyperglycemia; Metabolic Diseases
• Other Study ID Numbers: NCT01225588