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

Primary Purpose

it is a Group of Metabolic Diseases in, Which a Person Has High Blood Sugar, Either, Because the Body Does Not Produce Enough Insulin,

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Taurine
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for it is a Group of Metabolic Diseases in focused on measuring Taurine,Diabetes mellitus,oxidative stress,glycemic control

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Placebo Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Diabetes Mellitus type 1 taurine

    Diabetes mellitus type 1 placebo

    Diabetes type 2 taurine

    Diabetes type 2 placebo

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 21, 2010
    Last Updated
    November 7, 2012
    Sponsor
    Hamad Medical Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01226537
    Brief Title
    Effect of Taurine on Glycemic Control in Type I and Type II Diabetic Patients
    Official Title
    Effect of Taurine on Glycemic Control in Type I and Type II Diabetic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    November 2013 (Anticipated)
    Study Completion Date
    December 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hamad Medical Corporation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Diabetes Mellitus type 1 taurine
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Diabetes mellitus type 1 placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Diabetes type 2 taurine
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Diabetes type 2 placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    Taurine
    Intervention Description
    500 mg taurine capsules twice per day for 6 months
    Primary Outcome Measure Information:
    Title
    Fasting glucose 2) HbA1c 3) Lipid profile 4) Taurine 5) Insulin 6) Urine Micro albumin 7) Eye test
    Description
    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
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or Female Above 18-65 Years of old Known diabetic patients with HbA1c>8.0% 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shajitha Thekkeveetil, PhD
    Phone
    00974-44395096
    Email
    sveetil@hmc.org.qa
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yousef Al Ansari, MD
    Phone
    00974-2112754
    Email
    yalansari@hmc.org.qa

    12. IPD Sharing Statement

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

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