Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

Tanta University52 enrolled

Overview

This study aims at investigating the possible effect of alpha-lipoic acid on endothelial dysfunction and atherosclerosis in children with type 1 diabetes mellitus.

Endothelial dysfunction and alterations in vascular structure are early indicators of future cardiovascular events. The atherosclerotic changes begin much earlier than the appearance of clinical disease. Endothelial dysfunction in diabetes may be the result of a combination of multiple stressors. In the patients with type 1 diabetes, a significant increase in the concentrations of endothelial markers was already observed at the early stages of the disease including vascular cell adhesion molecules (VCAM-1), intercellular adhesion molecules (sICAM-1), soluble E- selectin E (sE-Selektin), asymmetric dimethylarginine (ADMA), plasminogen activator inhibitor 1 (PAI-1) because their concentrations increase rapidly in states of cellular stress. Increased carotid intima-media thickness (CIMT) is a structural marker for early atherosclerosis that correlates with cardio-vascular risk factors. Alpha -lipoic acid supplementation may have role in Improving Endothelial Dysfunction and early Atherosclerosis due to its oxidative and anti-inflammatory effect.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes MellitusType 1

Interventions

PlaceboOTHER

Inactive capsules

Alpha Lipoic Acid 600 MG Oral CapsuleDRUG

Universal antioxidant

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The change in carotid artery intima-media thickness (CIMT)

Measurement of carotid intima-media thickness (CIMT) which is mainly used to assess subclinical atherosclerosias and its assessment is based on ultrasound transducer