Alpha-lipoic Acid in Diabetic Nephropathy

February 8, 2024 updated by: Ain Shams University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Shymaa El-Morsy
  • Phone Number: 01275207244

Study Locations

  • Egypt
      • Cairo, Egypt, 11765
        • Recruiting
        • Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University
        • Contact:
          • Yasmine Ehenawyl
          • Phone Number: +201006714334

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interventional arm

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
Drug: Thioctic Acid 333 MG Oral Capsule
Antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes
Other Names:
  • Alpha lipoic acid 300 mg tablet
Drug: Captopril 25Mg Tab
Oral angiotensin-converting enzyme inhibitors
Other Names:
  • Capoten 25 mg tab
Placebo Comparator: Control Arm
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
Drug: Captopril 25Mg Tab
Oral angiotensin-converting enzyme inhibitors
Other Names:
  • Capoten 25 mg tab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Total antioxidant capacity and Malondialdehyde
Time Frame: 3 months
Changes in Total antioxidant capacity and Malondialdehyde
3 months
Changes in urinary albumin excretion rate
Time Frame: 3 months
Changes in urinary albumin excretion rate and HbA1c
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Yasmine I Elhenawy, ain shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS 662/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

Clinical Trials on Thioctic Acid 333 MG Oral Capsule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe