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This study aims at investigating the possible effect of alpha-lipoic acid on endothelial dysfunction and atherosclerosis in children with type 1 diabetes mellitus.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Inactive capsules |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara SA Harby, Master | Contact | 01128743303 | saraharby171@gmail.com | |
| Tarek TM Mostafa, Professor | Contact | 01154594035 | tarek.mostafa@pharm.tanta.edu.eg |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Alpha Lipoic Acid 600 MG Oral Capsule |
| Drug |
Universal antioxidant |
|
|
| 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 |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |