Clinical trial NCT05679037: Role of Alpha-lipoic Acid in Diabetes Melitus Type 1
Official title: The Possible Role of Alpha-Lipoic Acid in Improving Endothelial Dysfunction and Atherosclerosis in Children With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes MellitusType 1
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 52
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The change in carotid artery intima-media thickness (CIMT)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: The change in serum level of hs-CRP
timeFrame: Baseline and 6 months
measure: The change in serum level (MDA)
timeFrame: Baseline and 6 months
measure: The change in the serum level of VCAM-1
timeFrame: Baseline and 6 months
measure: The change in the serum level of Apelin
timeFrame: Baseline and 6 months
measure: Lipid profile measuremt
timeFrame: Baseline and 6 months
measure: Change in plasma level of (HbA1c %)
timeFrame: Baseline and 3,6 months
measure: Fast blood glucose measuremt
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
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