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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06253429
Other study ID # FMASU MS 662/2022
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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