Effect of Taurine on Glycemic Control in Type I and Type II Diabetic Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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. |
Drug: Taurine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Taurine on Glycemic Control in Type I and Type II Diabetic Patients |
- Fasting glucose 2) HbA1c 3) Lipid profile 4) Taurine 5) Insulin 6) Urine Micro albumin 7) Eye test [ Time Frame: 9 months ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Shajitha Thekkeveetil, PhD | 00974-44395096 | sveetil@hmc.org.qa |
| Contact: Yousef Al Ansari, MD | 00974-2112754 | yalansari@hmc.org.qa |
More Information
No publications provided
| Responsible Party: | Hamad Medical Corporation |
| ClinicalTrials.gov Identifier: | NCT01226537 History of Changes |
| Obsolete Identifiers: | NCT01225588 |
| Other Study ID Numbers: | NCT01225588 |
| Study First Received: | October 21, 2010 |
| Last Updated: | November 7, 2012 |
| Health Authority: | Supreme Council of Health: |
Keywords provided by Hamad Medical Corporation:
|
Taurine,Diabetes mellitus,oxidative stress,glycemic control |
Additional relevant MeSH terms:
|
Hyperglycemia Metabolic Diseases Glucose Metabolism Disorders |
ClinicalTrials.gov processed this record on May 19, 2013