Alpha-lipoic Acid in Diabetic Nephropathy

Type 1 Diabetes Clinical Trial

Official title:

Oxidative Stress in Children and Adolescents With Diabetic Nephropathy and the Role of Adjuvant Alpha-lipoic Acid as an Antioxidant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06253429
• Other study ID #: FMASU MS 662/2022
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: Yasmine I Elhenawy
• Phone: 01006714334
• Email: dr_yasmi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Type 1 Diabetes

Intervention

Drug:
• Thioctic Acid 333 MG Oral Capsule
Antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes
• Captopril 25Mg Tab
Oral angiotensin-converting enzyme inhibitors

Locations

Country	Name	City	State
Egypt	Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Total antioxidant capacity and Malondialdehyde	Changes in Total antioxidant capacity and Malondialdehyde	3 months
Primary	Changes in urinary albumin excretion rate	Changes in urinary albumin excretion rate and HbA1c	3 months