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

NCT01226537 | Unknown Phase 1 DMC

• 1 other identifier: NCT01225588
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

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.

Keywords

Taurine,Diabetes mellitus,oxidative stress,glycemic control

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Diabetes Mellitus type 1 taurine

ACTIVE COMPARATOR

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

Diabetes mellitus type 1 placebo

PLACEBO COMPARATOR

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

Diabetes type 2 taurine

ACTIVE COMPARATOR

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

Diabetes type 2 placebo

PLACEBO COMPARATOR

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

Interventions

Taurine DRUG

500 mg taurine capsules twice per day for 6 months

Diabetes Mellitus type 1 taurine; Diabetes mellitus type 1 placebo; Diabetes type 2 placebo; Diabetes type 2 taurine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female
• Above 18-65 Years of old
• Known diabetic patients with HbA1c\>8.0%
• People who provide signed informed consent -

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

MeSH Terms

Interventions

Taurine

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Shajitha Thekkeveetil, PhD

CONTACT

00974-44395096; sveetil@hmc.org.qa

Yousef Al Ansari, MD

CONTACT

00974-2112754; yalansari@hmc.org.qa

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 22, 2010
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2014
• Last Updated: November 9, 2012

Record last verified: 2012-11