Alpha-lipoic Acid in Diabetic Nephropathy

Ain Shams University

Status and phase: Enrolling; Phase 3

Conditions: Type 1 Diabetes

Treatments: Drug: Captopril 25Mg Tab; Drug: Thioctic Acid 333 MG Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06253429

FMASU MS 662/2022

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Interventional arm

Active Comparator group

Description:

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

Treatment:

Drug: Thioctic Acid 333 MG Oral Capsule

Drug: Captopril 25Mg Tab

Control Arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Captopril 25Mg Tab