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NCT05679037
Role of Alpha-lipoic Acid in Diabetes Melitus Type 1
Conditions: Diabetes MellitusType 1
Sex: All
Ages: 12 Years – 18 Years
Phase: PHASE3
Enrollment: 52
Sponsor: Tanta University
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.
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.
Source: ClinicalTrials.gov (NCT05679037). StuddyBuddy aggregates publicly available trial information.