Because the Body Does Not Produce Enough Insulin, Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | December 2014 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hamad Medical Corporation |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |