Alpha-lipoic Acid in Diabetic Nephropathy
- Conditions
- Type 1 Diabetes
- Interventions
- Drug: Thioctic Acid 333 MG Oral Capsule
- Registration Number
- NCT06253429
- Lead Sponsor
- Ain Shams University
- Brief 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.
- Detailed Description
Better understanding of the pathogenesis of microvascular complications in type 1 diabetes have paved the way for novel therapeutic targets and possible adjuvant therapeutic modalities. Oxidative stress is considered a common and important factor that links hyperglycemia with the vascular complications in diabetes, including of diabetic nephropathy (DN).
Alpha lipoic acid (ALA), or thioctacid, is an antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes. ALA can scavenge free radicals, activate antioxidant systems, and also affect inflammatory markers. It also has unique characteristic. ALA can play as a reduction for oxidized forms of components with antioxidant properties and neutralize reactive oxygen species. Thus, it called as antioxidant of antioxidants
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Children and adolescents with type 1 diabetes
- The presence of diabetic nephropathy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional arm Thioctic Acid 333 MG Oral Capsule 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 Control Arm Captopril 25Mg Tab 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 Interventional arm Captopril 25Mg Tab 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
- Primary Outcome Measures
Name Time Method Changes in Total antioxidant capacity and Malondialdehyde 3 months Changes in Total antioxidant capacity and Malondialdehyde
Changes in urinary albumin excretion rate 3 months Changes in urinary albumin excretion rate and HbA1c
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University
🇪🇬Cairo, Egypt