Oxidative Stress in Children and Adolescents With Diabetic Nephropathy and the Role of Adjuvant Alpha-lipoic Acid as an Antioxidant
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Endothelial dysfunction in diabetes is a central event in the pathogenesis of different microangioapthic changes. Nephropathy in patients with type 1 diabetes is a severe microvascular complication.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:
• Children and adolescents with type 1 diabetes
• The presence of diabetic nephropathy
Locations
Other Locations
Egypt
Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University
RECRUITING
Cairo
Contact Information
Primary
Yasmine I Elhenawy
dr_yasmi@yahoo.com
01006714334
Backup
Shymaa El-Morsy
01275207244
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2024-02-01
Participants
Target number of participants: 30
Treatments
Active_comparator: Interventional arm
including pediatric patients with diabetic nephropathy receiving oral alpha-lipoic acid daily.~The capsule of ALA ( Thiotex 300 mg capsule) contains 300 mg of thioctic acid, manufactured bt Marcyrl Pharmaceutical Industries - Egypt.) The patient will receive 1 capsule twice daily for 3 months. Patients' compliance to therapy will be checked by counting pills.~oral angiotensin-converting enzyme inhibitors (ACE-Is) captopril 25 mg tablet provided their blood pressure will be maintained within normal range for age
Placebo_comparator: Control Arm
including pediatric patients with diabetic nephropathy receiving placebo that is similar in appearance to the oral alpha-lipoic acid (Thiotex 300 mg capsule) and oral angiotensin-converting enzyme inhibitors (ACE-Is)(Captopril 25 mg tablet) provided their blood pressure will be maintained within normal range for age
Related Therapeutic Areas
Sponsors
Leads: Ain Shams University