Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

Tanta University

Status and phase: Not yet enrolling; Phase 3

Conditions: Diabetes MellitusType 1

Treatments: Drug: Alpha Lipoic Acid 600 MG Oral Capsule; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05679037

Role of ALA in diabetes

Details and patient eligibility

About

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

Full description

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Placebo group who received insulin only plus placebo tablets

Placebo Comparator group

Description:

(Placebo group; n=22) which will receive insulin plus placebo tablets once daily for 6 months.

Treatment:

Other: Placebo

ALA group who received Alpha lipoic acid plus insulin

Active Comparator group

Description:

(alpha-lipoic acid group; n=22) which will receive insulin plus ALA 600mg once daily for 6 months.

Treatment:

Drug: Alpha Lipoic Acid 600 MG Oral Capsule