Role of Alpha-lipoic Acid in Diabetes Melitus Type 1
- Conditions
- Diabetes MellitusType 1
- Interventions
- Other: PlaceboDrug: Alpha Lipoic Acid 600 MG Oral Capsule
- Registration Number
- NCT05679037
- Lead Sponsor
- Tanta University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group who received insulin only plus placebo tablets Placebo (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 Alpha Lipoic Acid 600 MG Oral Capsule (alpha-lipoic acid group; n=22) which will receive insulin plus ALA 600mg once daily for 6 months.
- Primary Outcome Measures
Name Time Method 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
Name Time Method The change in serum level (MDA) Baseline and 6 months Malondialdehyde (MDA) which will be assessed by colorimetric method.
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.
The change in the serum level of Apelin Baseline and 6 months Serum Apelin a marker of atherosclerosis which will be assessed by ELISA
Fast blood glucose measuremt Baseline and 6 months Fasting blood glucose will be determined by glucose oxidase 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.
Change in plasma level of (HbA1c %) Baseline and 3,6 months Glycated hemoglobin (HbA1c %) will be measured by ion exchange micro-column chromatographic method.
Lipid profile measuremt Baseline and 6 months Total cholesterol (TC), triglyceride (TG) and HDL-C will be assessed by enzymatic colorimetric method.