Possible Ameliorating Effect of N- Acetylcysteine (NAC) on Type-II Diabetes Induced Nephropathy

Al-Azhar University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Diabetic Nephropathies; Diabetes Mellitus, Type 2; Diabetic Kidney Disease

Treatments: Drug: N Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT04531163

AlAzharUn

Details and patient eligibility

About

The study is focused on the possible improving effect of N-acetylcysteine on nephropathy of type-2 diabetic patients.

Study design: Prospective clinical based study. The aim of this work is to study the effect of N-acetylcysteine (NAC) on proteinuria and on the serum level of lipoprotein a (LPa) in diabetes induced nephropathy in type-2 diabetic patients.

Full description

This study will be carried on 60 participants with Type 2 Diabetes with age over 20 years.

Participants will be classified into two groups:

1. Group I (Interventional): treated with (NAC) dose of 1200 mg/day for two months in conjunction with conventional treatment.
2. Group II (Non-interventional): control group receive conventional treatment.

All patients will undergo the following:

1. Full medical history will be taken.
2. Laboratory investigations as follows:

Blood samples will be collected for analysis after overnight fasting at the beginning and after 2 months of the study for determination of:

1. Total cholesterol (T-chol).
2. Plasma triglycerides (TG).
3. High density lipoprotein cholesterol (HDL-C).
4. Low density lipoprotein cholesterol (LDL-C).
5. Fasting blood sugar.
6. Blood urea nitrogen (BUN).
7. Serum creatinine (SCr).
8. Urine analysis.
9. Glycated hemoglobin (HbA1c).
10. Lipoprotein (a). In addition, blood pressure will be measured for 24 hr.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Confirmed diagnosis of Diabetes Mellitus.
2. Age over 20 years.
3. Patients with proteinuria ≥ 30 mg /dl.

Exclusion criteria

1. Patients on lipid lowering medications.
2. Cigarette smokers.
3. Presence of liver and heart diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Interventional

Experimental group

Description:

First arm is experimental, given (NAC) for 2 months in 1200mg/day dosing. Both arms are assigned to pre-treatment analytical tests and post treatment all test analysis are repeated to compare drug effect with placebo group.

Treatment:

Drug: N Acetylcysteine

Non-interventional

No Intervention group

Description:

Second arm has no intervention. It is only used to compare results of analytical tests with the first interventional arm.