Alpha-lipoic Acid in Diabetic Nephropathy

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06253429

Enrollment

Registered

2024-02-12

Start date

2023-01-01

Completion date

2024-02-01

Last updated

2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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

Interventions

DRUGThioctic Acid 333 MG Oral Capsule

Antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes

DRUGCaptopril 25Mg Tab

Oral angiotensin-converting enzyme inhibitors

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Contacts

Primary ContactYasmine I Elhenawy

dr_yasmi@yahoo.com01006714334

Backup ContactShymaa El-Morsy

01275207244

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026