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

Phase 2

• Conditions: Diabetes Mellitus, Type 2; Diabetic Nephropathies; Diabetic Kidney Disease
• Interventions: Drug: N Acetylcysteine

• Registration Number: NCT04531163
• Lead Sponsor: Al-Azhar University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-10-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-26
• Last Update Submitted: 2020-08-26
• Study First Posted: 2020-08-28
• Last Update Posted: 2020-08-28
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	N Acetylcysteine	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.

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	2 months	The first number of blood pressure reading and it indicates how much pressure our blood is exerting against our artery walls when the heart beats. It is a major risk factor for cardiovascular disease.
Lipoprotein (a)	2 months	unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.
Triglycerides	2 months	Triglycerides are a type of fat (lipid) found in our blood. It is one of the lipid panel used to determine atherosclerotic risk that contributes to vascular diseases.

Trial Locations

Locations (1)

Al Azhar University; 🇪🇬 Cairo, Egypt