Diabetes MellitusType 1
Conditions
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.
Interventions
OTHERPlacebo
Inactive capsules
Universal antioxidant
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The change in serum level (MDA) | Baseline and 6 months | Malondialdehyde (MDA) which will be assessed by colorimetric method. |
| 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. |
| The change in the serum level of Apelin | Baseline and 6 months | Serum Apelin a marker of atherosclerosis which will be assessed by ELISA |
| 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. |
| Change in plasma level of (HbA1c %) | Baseline and 3,6 months | Glycated hemoglobin (HbA1c %) will be measured by ion exchange micro-column chromatographic method. |
| Fast blood glucose measuremt | Baseline and 6 months | Fasting blood glucose will be determined by glucose oxidase method. |
| Lipid profile measuremt | Baseline and 6 months | Total cholesterol (TC), triglyceride (TG) and HDL-C will be assessed by enzymatic colorimetric method. |
Contacts
Primary ContactSara SA Harby, Master
Backup ContactTarek TM Mostafa, Professor
Outcome results
None listed