Diabetic Kidney DiseasePhase 2/3(NAC)NCT04531163
Possible Ameliorating Effect of N- Acetylcysteine (NAC) on Type-II Diabetes Induced Nephropathy
A Phase 2/3 study testing N Acetylcysteine in people with Diabetic Kidney Disease and Diabetes Mellitus, Type 2, run by Al-Azhar University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Kidney Disease, Diabetes Mellitus, Type 2, Diabetic Nephropathies
- What is being tested?
- N Acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Diabetes Mellitus.
- Age over 20 years.
- Patients with proteinuria ≥ 30 mg /dl.
Who cannot join
- Patients on lipid lowering medications.
- Cigarette smokers.
- Presence of liver and heart diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- N Acetylcysteine
- 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
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N AcetylcysteineDrug
Also called (NAC), Fluimucil
(NAC) is a drug used in the experiment and participant are treated with it by 1200mg/day dose for two months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipoprotein (a)
unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.
Measured: 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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Oct 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Ahmed Hamed, Al-Azhar University
- Investigators
- Huda M. Salem, PhD, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531163
- Sponsor's protocol ID
- AlAzharUn
- Acronym
- (NAC)
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Ameliorating Effect of N- Acetylcysteine on Type-II Diabetes Induced Nephropathy
- ClinicalTrials.gov ID
- NCT04531163
- Acronym / sponsor ID
- (NAC) / AlAzharUn
- Keywords
- N-Acetyl cysteine, Lipoprotein a, Triglycerides, Total cholesterol, Glycated Haemoglobin, Fasting blood sugar, Serum creatinine, Blood urea nitrogen
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Drug: N AcetylcysteineFirst 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. |
| Non-interventional | No intervention | –Second arm has no intervention. It is only used to compare results of analytical tests with the first interventional arm. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of Diabetes Mellitus.
- Age over 20 years.
- Patients with proteinuria ≥ 30 mg /dl.
Key exclusion criteria (3 listed)
- Patients on lipid lowering medications.
- Cigarette smokers.
- Presence of liver and heart diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N AcetylcysteineAlso: (NAC), Fluimucil(NAC) is a drug used in the experiment and participant are treated with it by 1200mg/day dose for two months. | Drug | Interventional |
Primary outcome
Lipoprotein (a)
Time frame: 2 months
unique lipoprotein that has emerged as an independent risk factor for developing vascular disease.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetic Kidney Disease
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huda M. Salem, PhD study chair
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing N Acetylcysteine in people with Diabetic Kidney Disease and Diabetes Mellitus, Type 2, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipoprotein (a) (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.