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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04531163
Other study ID # AlAzharUn
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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