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

August 26, 2020 updated by: Tasneem Ahmed Hamed, Al-Azhar University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11651
        • Al Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: N Acetylcysteine
(NAC) is a drug used in the experiment and participant are treated with it by 1200mg/day dose for two months.
Other Names:
  • Fluimucil
  • (NAC)
No Intervention: Non-interventional
Second arm has no intervention. It is only used to compare results of analytical tests with the first interventional arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipoprotein (a)
Time Frame: 2 months
unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.
2 months
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.
2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Study Chair: Huda M. Salem, PhD, AlAzhar university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlAzharUn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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