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

Diabetes Mellitus, Type 2 Clinical Trial

— (NAC)  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04531163
• Other study ID #: AlAzharUn
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: August 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

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

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipoprotein (a)	unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.	2 months
Primary	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.	2 months
Primary	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.	2 months