The Possible Role of Alpha-Lipoic Acid in Improving Endothelial Dysfunction and Atherosclerosis in Children With Type 1 Diabetes Mellitus
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Diabetes MellitusType 1
- Sponsor
- Tanta University
- Enrollment
- 52
- Primary Endpoint
- The change in carotid artery intima-media thickness (CIMT)
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Sara Ahmed mohamed Attia Harby
Administrator at faculty of pharmacy, Tanta university
Tanta University
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.
Arms & Interventions
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.
Intervention: Placebo
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.
Intervention: Alpha Lipoic Acid 600 MG Oral Capsule
Outcomes
Primary Outcomes
The change in carotid artery intima-media thickness (CIMT)
Time Frame: 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 Outcomes
- The change in serum level (MDA)(Baseline and 6 months)
- The change in serum level of hs-CRP(Baseline and 6 months)
- The change in the serum level of Apelin(Baseline and 6 months)
- Fast blood glucose measuremt(Baseline and 6 months)
- The change in the serum level of VCAM-1(Baseline and 6 months)
- Change in plasma level of (HbA1c %)(Baseline and 3,6 months)
- Lipid profile measuremt(Baseline and 6 months)