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

NCT ID: NCT04531163

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-12-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

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.

Group Type: EXPERIMENTAL

N Acetylcysteine

Intervention Type: DRUG

(NAC) is a drug used in the experiment and participant are treated with it by 1200mg/day dose for two months.

Non-interventional

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

N Acetylcysteine

(NAC) is a drug used in the experiment and participant are treated with it by 1200mg/day dose for two months.

Intervention Type: DRUG

Other Intervention Names

(NAC); Fluimucil

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Tasneem Ahmed Hamed

Clinical pharamacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huda M. Salem, PhD

Role: STUDY_CHAIR

Al-Azhar University

Locations

Al Azhar University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AlAzharUn

Identifier Type: -

Identifier Source: org_study_id