Alpha-lipoic Acid in Diabetic Nephropathy

NCT06253429 | Unknown Phase 3 DMC

• 1 other identifier: FMASU MS 662/2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Changes in Total antioxidant capacity and Malondialdehyde

  Changes in Total antioxidant capacity and Malondialdehyde

  3 months

• Changes in urinary albumin excretion rate

  Changes in urinary albumin excretion rate and HbA1c

  3 months

Study Arms (2)

Interventional arm

ACTIVE COMPARATOR

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; Drug: Captopril 25Mg Tab

Control Arm

PLACEBO COMPARATOR

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

Interventions

Thioctic Acid 333 MG Oral Capsule DRUG

Antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes

Also known as: Alpha lipoic acid 300 mg tablet

Interventional arm

Captopril 25Mg Tab DRUG

Oral angiotensin-converting enzyme inhibitors

Also known as: Capoten 25 mg tab

Control Arm; Interventional arm

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, 11765, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Thioctic Acid; Tablets; Captopril

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yasmine I Elhenawy

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmine I Elhenawy

CONTACT

01006714334; dr_yasmi@yahoo.com

Shymaa El-Morsy

CONTACT

01275207244

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 12, 2024
• Study Start: January 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 1, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)