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

NCT ID: NCT01226537

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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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

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Taurine,Diabetes mellitus,oxidative stress,glycemic control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Taurine

Intervention Type DRUG

500 mg taurine capsules twice per day for 6 months

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.

Group Type PLACEBO_COMPARATOR

Taurine

Intervention Type DRUG

500 mg taurine capsules twice per day for 6 months

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.

Group Type ACTIVE_COMPARATOR

Taurine

Intervention Type DRUG

500 mg taurine capsules twice per day for 6 months

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.

Group Type PLACEBO_COMPARATOR

Taurine

Intervention Type DRUG

500 mg taurine capsules twice per day for 6 months

Interventions

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Taurine

500 mg taurine capsules twice per day for 6 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamad Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Shajitha Thekkeveetil, PhD

Role: CONTACT

Phone: 00974-44395096

Email: [email protected]

Yousef Al Ansari, MD

Role: CONTACT

Phone: 00974-2112754

Email: [email protected]

Other Identifiers

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NCT01225588

Identifier Type: -

Identifier Source: org_study_id

NCT01225588

Identifier Type: -

Identifier Source: nct_alias