Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

The Possible Role of Alpha-Lipoic Acid in Improving Endothelial Dysfunction and Atherosclerosis in Children With Type 1 Diabetes Mellitus

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes MellitusType 1
• Intervention / Treatment: Other: Placebo; Drug: Alpha Lipoic Acid 600 MG Oral Capsule

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.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sara SA Harby, Master; Phone Number: 01128743303; Email: saraharby171@gmail.com
• Study Contact Backup: Name: Tarek TM Mostafa, Professor; Phone Number: 01154594035; Email: tarek.mostafa@pharm.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Other: Placebo; Inactive capsules
Active Comparator: 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.	Drug: Alpha Lipoic Acid 600 MG Oral Capsule; Universal antioxidant; Other Names: Thioctic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in serum level of hs-CRP	High sensitivity C- reactive protein (hs-CRP) which will be assessed by ELISA.	Baseline and 6 months
The change in serum level (MDA)	Malondialdehyde (MDA) which will be assessed by colorimetric method.	Baseline and 6 months
The change in the serum level of VCAM-1	Vascular cell adhesion molecule-1 (VCAM-1) a marker of endothelial dysfunction which will be assessed by ELISA.	Baseline and 6 months
The change in the serum level of Apelin	Serum Apelin a marker of atherosclerosis which will be assessed by ELISA	Baseline and 6 months
Lipid profile measuremt	Total cholesterol (TC), triglyceride (TG) and HDL-C will be assessed by enzymatic colorimetric method.	Baseline and 6 months
Change in plasma level of (HbA1c %)	Glycated hemoglobin (HbA1c %) will be measured by ion exchange micro-column chromatographic method.	Baseline and 3,6 months
Fast blood glucose measuremt	Fasting blood glucose will be determined by glucose oxidase method.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 8, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Thioctic Acid
• Other Study ID Numbers: Role of ALA in diabetes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No