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

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
N Acetylcysteine
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring N-Acetyl cysteine, Lipoprotein a, Triglycerides, Total cholesterol, Glycated Haemoglobin, Fasting blood sugar, Serum creatinine, Blood urea nitrogen, Urine analysis, High density lipoprotein, Low density lipoprotein

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Al Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional

Non-interventional

Arm Description

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.

Second arm has no intervention. It is only used to compare results of analytical tests with the first interventional arm.

Outcomes

Primary Outcome Measures

Lipoprotein (a)
unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2020
Last Updated
August 26, 2020
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04531163
Brief Title
Possible Ameliorating Effect of N- Acetylcysteine (NAC) on Type-II Diabetes Induced Nephropathy
Acronym
(NAC)
Official Title
Possible Ameliorating Effect of N- Acetylcysteine on Type-II Diabetes Induced Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Group I (Interventional): treated with (NAC) dose of 1200 mg/day for two months in conjunction with conventional treatment. Group II (Non-interventional): control group receive conventional treatment. All patients will undergo the following: Full medical history will be taken. 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: Total cholesterol (T-chol). Plasma triglycerides (TG). High density lipoprotein cholesterol (HDL-C). Low density lipoprotein cholesterol (LDL-C). Fasting blood sugar. Blood urea nitrogen (BUN). Serum creatinine (SCr). Urine analysis. Glycated hemoglobin (HbA1c). Lipoprotein (a). In addition, blood pressure will be measured for 24 hr.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease, Diabetes Mellitus, Type 2, Diabetic Nephropathies
Keywords
N-Acetyl cysteine, Lipoprotein a, Triglycerides, Total cholesterol, Glycated Haemoglobin, Fasting blood sugar, Serum creatinine, Blood urea nitrogen, Urine analysis, High density lipoprotein, Low density lipoprotein

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Two arms are being used parallel to each other at the same time. Participants are assigned to two groups in parallel for the duration of the study. One arm is interventional assigned to drug administration and the other is a control arm.
Masking
None (Open Label)
Masking Description
All participants,investigators, care providers, and outcome assessor have knowledge of the interventions assigned to individual participants.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-interventional
Arm Type
No Intervention
Arm Description
Second arm has no intervention. It is only used to compare results of analytical tests with the first interventional arm.
Intervention Type
Drug
Intervention Name(s)
N Acetylcysteine
Other Intervention Name(s)
(NAC), Fluimucil
Intervention Description
(NAC) is a drug used in the experiment and participant are treated with it by 1200mg/day dose for two months.
Primary Outcome Measure Information:
Title
Lipoprotein (a)
Description
unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.
Time Frame
2 months
Title
Triglycerides
Description
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
Title
Systolic blood pressure
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huda M. Salem, PhD
Organizational Affiliation
ALAZHAR UNIVERSITY
Official's Role
Study Chair
Facility Information:
Facility Name
Al Azhar University
City
Cairo
ZIP/Postal Code
11651
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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