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

NCT04531163 | Unknown Phase 2 DMC

• 1 other identifier: AlAzharUn
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Lipoprotein (a)

  unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.

  2 months

• 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

• 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

Study Arms (2)

Interventional

EXPERIMENTAL

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

Non-interventional

NO INTERVENTION

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

Interventions

N Acetylcysteine DRUG

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

Also known as: (NAC), Fluimucil

Interventional

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Diabetes Mellitus.
• Age over 20 years.
• Patients with proteinuria ≥ 30 mg /dl.

You may not qualify if:

• Patients on lipid lowering medications.
• Cigarette smokers.
• Presence of liver and heart diseases.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar University

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Huda M. Salem, PhD

  Al-Azhar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All participants,investigators, care providers, and outcome assessor have knowledge of the interventions assigned to individual participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharamacist

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 28, 2020
• Study Start: October 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)