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

Al-Azhar University60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Kidney Disease Diabetes Mellitus, Type 2 Diabetic Nephropathies

Interventions

N AcetylcysteineDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Al Azhar University

Cairo, Egypt

Outcomes

Primary Outcomes

Lipoprotein (a)

unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.

Time frame: 2 months

Triglycerides

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.

Time frame: 2 months

Systolic blood pressure

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.

Time frame: 2 months

Data from ClinicalTrials.gov

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