Using Alpha-lipoic Acid to Treat Diabetic Nephropathy in Type 1 Diabetes
Oxidative Stress in Children and Adolescents With Diabetic Nephropathy and the Role of Adjuvant Alpha-lipoic Acid as an Antioxidant
This study is testing if adding Alpha-lipoic Acid to a common kidney medication can help children and teens with type 1 diabetes improve their kidney health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06253429 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Alpha-lipoic Acid (ALA) on diabetic nephropathy in children and adolescents with type 1 diabetes. ALA is an antioxidant that may help reduce oxidative stress and inflammation associated with diabetic complications. The study will involve administering ALA alongside Captopril to evaluate its efficacy in improving kidney function and overall health in participants. The trial aims to provide insights into novel therapeutic approaches for managing diabetic nephropathy.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents diagnosed with type 1 diabetes who also have diabetic nephropathy.
Not a fit: Patients with renal impairment due to causes other than diabetes or those with other diabetic complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve kidney health and quality of life for patients with type 1 diabetes and nephropathy.
How similar studies have performed: While the use of antioxidants in diabetic complications has been explored, this specific approach with ALA in diabetic nephropathy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children and adolescents with type 1 diabetes * The presence of diabetic nephropathy Exclusion Criteria: * Renal impairment due to causes other than diabetes * Other diabetic complications than nephropathy * Elevated liver enzymes * Hypersensitivity to lipoic acid * Participation in a previous investigational drug study within the 30 days preceding screening
Where this trial is running
Cairo
- Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Yasmine I Elhenawy — Ain Shams University
- Study coordinator: Yasmine I Elhenawy
- Email: dr_yasmi@yahoo.com
- Phone: 01006714334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.