Possible Ameliorating Effect of N- Acetylcysteine on Type-II Diabetes Induced Nephropathy
Overview
- Phase
- Phase 2
- Intervention
- N Acetylcysteine
- Conditions
- Diabetic Kidney Disease
- Sponsor
- Al-Azhar University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Lipoprotein (a)
- Last Updated
- 5 years ago
Overview
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.
Investigators
Tasneem Ahmed Hamed
Clinical pharamacist
Al-Azhar University
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of Diabetes Mellitus.
- •Age over 20 years.
- •Patients with proteinuria ≥ 30 mg /dl.
Exclusion Criteria
- •Patients on lipid lowering medications.
- •Cigarette smokers.
- •Presence of liver and heart diseases.
Arms & Interventions
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.
Intervention: N Acetylcysteine
Outcomes
Primary Outcomes
Lipoprotein (a)
Time Frame: 2 months
unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.
Systolic blood pressure
Time Frame: 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.
Triglycerides
Time Frame: 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.