Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

• Sponsor: Tanta University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05679037
• Collaborator: (none)
• Enrollment: 52
• Arms: 2
• Anticipated Duration (Months): 22

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes MellitusType 1	Other: Placebo; Drug: Alpha Lipoic Acid 600 MG Oral Capsule	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Possible Role of Alpha-Lipoic Acid in Improving Endothelial Dysfunction and Atherosclerosis in Children With Type 1 Diabetes Mellitus
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The change in carotid artery intima-media thickness (CIMT) [Baseline and 6 months]

   Measurement of carotid intima-media thickness (CIMT) which is mainly used to assess subclinical atherosclerosias and its assessment is based on ultrasound transducer

Secondary Outcome Measures

1. The change in serum level of hs-CRP [Baseline and 6 months]

   High sensitivity C- reactive protein (hs-CRP) which will be assessed by ELISA.

2. The change in serum level (MDA) [Baseline and 6 months]

   Malondialdehyde (MDA) which will be assessed by colorimetric method.

3. The change in the serum level of VCAM-1 [Baseline and 6 months]

   Vascular cell adhesion molecule-1 (VCAM-1) a marker of endothelial dysfunction which will be assessed by ELISA.

4. The change in the serum level of Apelin [Baseline and 6 months]

   Serum Apelin a marker of atherosclerosis which will be assessed by ELISA

5. Lipid profile measuremt [Baseline and 6 months]

   Total cholesterol (TC), triglyceride (TG) and HDL-C will be assessed by enzymatic colorimetric method.

6. Change in plasma level of (HbA1c %) [Baseline and 3,6 months]

   Glycated hemoglobin (HbA1c %) will be measured by ion exchange micro-column chromatographic method.

7. Fast blood glucose measuremt [Baseline and 6 months]

   Fasting blood glucose will be determined by glucose oxidase method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sara Ahmed mohamed Attia Harby, Administrator at faculty of pharmacy, Tanta university, Tanta University
• ClinicalTrials.gov Identifier: NCT05679037
• Other Study ID Numbers: Role of ALA in diabetes
• First Posted: Jan 10, 2023
• Last Update Posted: Jan 10, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Thioctic Acid

Study Results

No Results Posted as of Jan 10, 2023