Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Thioctic Acid

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.