Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

NCT ID: NCT05679037

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-11-30

Brief 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.

Detailed 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.

Conditions

Diabetes MellitusType 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo group who received insulin only plus placebo tablets

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Inactive capsules

ALA group who received Alpha lipoic acid plus insulin

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

Group Type: ACTIVE_COMPARATOR

Alpha Lipoic Acid 600 MG Oral Capsule

Intervention Type: DRUG

Universal antioxidant

Interventions

Placebo

Inactive capsules

Intervention Type: OTHER

Alpha Lipoic Acid 600 MG Oral Capsule

Universal antioxidant

Intervention Type: DRUG

Other Intervention Names

Thioctic acid

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sara Ahmed mohamed Attia Harby

Administrator at faculty of pharmacy, Tanta university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sara SA Harby, Master

Role: CONTACT

saraharby171@gmail.com

01128743303

Tarek TM Mostafa, Professor

Role: CONTACT

tarek.mostafa@pharm.tanta.edu.eg

01154594035

Other Identifiers

Role of ALA in diabetes

Identifier Type: -

Identifier Source: org_study_id