Role of Alpha-lipoic Acid in Diabetes Melitus Type 1
Diabetes MellitusType 1
About this trial
This is an interventional treatment trial for Diabetes MellitusType 1
Eligibility Criteria
Inclusion Criteria: Children with T1DM on insulin therapy ≥ 0.5 IU/kg/day. Age range between 12 and < 18 years old. Both sex. Duration of diabetes ≥ 3 years. Glycated hemoglobin of ≥ 7.5% Patients who are previously evaluated for endothelial dysfunction and atherosclerosis. Exclusion Criteria: Clinical evidence of heart failure, coronary artery disease, systemic hypertension, rheumatic fever, cardiomyopathy. Concurrent use of any medication other than insulin known to affect cardiac function (such as digitalis, angiotensin converting enzyme inhibitor, or β-blocker, etc…). Concurrent use of hyperlipidemia agents (Statin, fibrate). Concurrent use of antioxidants as selenium, vitamin C, vitamin E, etc.. Patients with inflammatory conditions. Patients with conditions predispose to oxidative stress (obesity, COPD, etc…). Patients with liver disease. Patients with thyroid disease. Patients with seizures.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo group who received insulin only plus placebo tablets
ALA group who received Alpha lipoic acid plus insulin
(Placebo group; n=22) which will receive insulin plus placebo tablets once daily for 6 months.
(alpha-lipoic acid group; n=22) which will receive insulin plus ALA 600mg once daily for 6 months.