Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

NCT05679037 | Unknown Phase 3

• 1 other identifier: Role of ALA in diabetes
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes MellitusType 1

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 6 months

Secondary Outcomes (7)

• The change in serum level of hs-CRP

  Baseline and 6 months

• The change in serum level (MDA)

  Baseline and 6 months

• The change in the serum level of VCAM-1

  Baseline and 6 months

• The change in the serum level of Apelin

  Baseline and 6 months

• Lipid profile measuremt

  Baseline and 6 months

Study Arms (2)

Placebo group who received insulin only plus placebo tablets

PLACEBO COMPARATOR

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

Other: Placebo

ALA group who received Alpha lipoic acid plus insulin

ACTIVE COMPARATOR

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

Drug: Alpha Lipoic Acid 600 MG Oral Capsule

Interventions

Placebo OTHER

Inactive capsules

Placebo group who received insulin only plus placebo tablets

Alpha Lipoic Acid 600 MG Oral Capsule DRUG

Universal antioxidant

Also known as: Thioctic acid

ALA group who received Alpha lipoic acid plus insulin

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Interventions

Thioctic Acid

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Central Study Contacts

Sara SA Harby, Master

CONTACT

01128743303; saraharby171@gmail.com

Tarek TM Mostafa, Professor

CONTACT

01154594035; tarek.mostafa@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrator at faculty of pharmacy, Tanta university

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 10, 2023
• Study Start: January 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 10, 2023

Record last verified: 2023-01