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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04531163
Recruitment Status : Active, not recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Tasneem Ahmed Hamed, Al-Azhar University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Diabetes Mellitus, Type 2 Diabetic Nephropathies Drug: N Acetylcysteine Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Treatment
Official Title: Possible Ameliorating Effect of N- Acetylcysteine on Type-II Diabetes Induced Nephropathy
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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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:
  • (NAC)
  • Fluimucil
No Intervention: Non-interventional
Second arm has no intervention. It is only used to compare results of analytical tests with the first interventional arm.


Outcome Measures
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Primary Outcome Measures :
  1. Lipoprotein (a) [ Time Frame: 2 months ]
    unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531163


Locations
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Egypt
Al Azhar University
Cairo, Egypt, 11651
Sponsors and Collaborators
Al-Azhar University
Investigators
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Study Chair: Huda M. Salem, PhD ALAZHAR UNIVERSITY
More Information
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Responsible Party: Tasneem Ahmed Hamed, Clinical pharamacist, Al-Azhar University
ClinicalTrials.gov Identifier: NCT04531163    
Other Study ID Numbers: AlAzharUn
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tasneem Ahmed Hamed, Al-Azhar University:
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
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Acetylcysteine
N-monoacetylcystine
 Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes