Alpha-lipoic Acid in Diabetic Nephropathy

Last updated: February 8, 2024
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 1

Treatment

Captopril 25Mg Tab

Thioctic Acid 333 MG Oral Capsule

Clinical Study ID

NCT06253429
FMASU MS 662/2022
  • Ages 6-18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Children and adolescents with type 1 diabetes
  • The presence of diabetic nephropathy

Exclusion

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 precedingscreening

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Captopril 25Mg Tab
Phase: 3
Study Start date:
January 01, 2023
Estimated Completion Date:
February 01, 2024

Study 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

Connect with a study center

  • Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University

    Cairo, 11765
    Egypt

    Active - Recruiting

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