Mafld in Ckd PatientsNCT06135467
Association Betweenq MAFLD ( Metabolic Associated Fatty Liver Disease) and Chronic Kidney Disease
An observational study of Mafld in Ckd Patients, run by Assiut University.
Trial summary
Assess frequency of renal affection in mafld Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mafld in Ckd Patients
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2025to 15 Nov 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the study is done on 150 patients diagnosed as MAFLD with its diagnostic criteria (Diagnostic criteria of MAFLD are ( steatosis with one of the following 1. BMI >25 2. type II DM 3. > 2 metabolic abnormalities [ 1)waist circumferance >94 in males or 80 in females 2)bp >130/85 3) plasma triglycrides > 150 mg / dl 4) HDL < 40 5)prediabetes 6) HOMA insulin resistance score >2.5 7)plasma hs CRP> 2 mg/dl ]. And divided into 3 groups : 1. MAFLD with type II DM 2. MAFLD not type II DM 3. control group
Who may be able to join
- CKD patients type II . III and type IV not on dialysis
- Patients with MAFLD
- patients with type II DM
Who cannot join
- Patients with AKI
- patients with NAFLD
- patients with alcoholic fatty liver disease
- patients with type I DM
- malignancy
- HBV HCV
- autoimmune disease
- liver cirrhosis
About this study
Official title: Association Between MAFLD ( Metabolic Associated Fatty Liver Disease) and Chronic Kidney Disease
Assess frequency of renal affection in mafld
Read the detailed description
Metabolic dysfunction-associated fatty liver disease (MAFLD) is a multisystem disorder, but its relationship with kidney injury remains controversial. This study aimed to evaluate MAFLD effects on the chronic kidney disease (CKD) frequency The association between metabolic dysfunction associated fatty liver disease (MAFlD) and extrahepatic disease is not known .the aim of this cross sectional study is to compare the frequency of CKD in patients with MAFLD and examine association between presence and severity of MAFLD and CKD and abnormal albuminuria.
Non-alcoholic fatty liver disease (NAFLD) is characterized by the accumulation of fat in more than 5% of hepatocytes in the absence of excessive alcohol consumption and other secondary causes of hepatic steatosis. In 2020, the more inclusive term metabolic (dysfunction)-associated fatty liver disease (MAFLD) - defined by broader diagnostic criteria - was proposed to replace the term NAFLD. The new terminology and revised definition better emphasize the pathogenic role of metabolic dysfunction and uses a set of definitive, inclusive criteria for diagnosis. Diagnosis of MAFLD is based on evidence of hepatic steatosis (as assessed by liver biopsy, imaging techniques or blood biomarkers and scores) in persons who are overweight or obese and have type 2 diabetes mellitus or metabolic dysregulation, regardless of the coexistence of other liver diseases or excessive alcohol consumption.
The known association between NAFLD and chronic kidney disease (CKD) and our understanding that CKD can occur as a consequence of metabolic dysfunction suggests that individuals with MAFLD - who by definition have fatty liver and metabolic comorbidities - are at increased risk of CKD.
MAFLD appears to be tightly linked to incident chronic kidney disease (CKD). This association may be attributed to multiple shared risk factors including type 2 diabetes mellitus, arterial hypertension, obesity, dyslipidemia, and insulin resistance Diagnostic criteria of MAFLD are ( steatosis with one of the following
- BMI >25
- type II DM
- > 2 metabolic abnormalities [ 1)waist circumferance >94 in males or 80 in females 2)bp >130/85 3) plasma triglycrides > 150 mg / dl 4) HDL < 40 5)prediabetes 6) HOMA insulin resistance score >2.5 7)plasma hs CRP> 2 mg/dl ]
- Conditions
- Mafld in Ckd Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of MAFLD in CKD patients 2_To screen early MAFLD in CKD patients 3_To association between MAFLD in CKD and type II DM patients
estimate the frequency of MAFLD in CKD patients 2_To screen early MAFLD in CKD patients 3_To association between MAFLD in CKD and type II DM patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start14 Apr 2025 (estimated)
- Primary completion14 Nov 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mafld in Ckd PatientsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa adel shehata, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135467
- Sponsor's protocol ID
- Mafld in ckd patients
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between MAFLD ( Metabolic Associated Fatty Liver Disease) and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06135467
- Acronym / sponsor ID
- Mafld in ckd patients
- Conditions
- Mafld in Ckd Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (estimated)
- Primary completion
- 14 Nov 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 18 Nov 2023 (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.
Assess frequency of renal affection in mafld
Detailed description
Metabolic dysfunction-associated fatty liver disease (MAFLD) is a multisystem disorder, but its relationship with kidney injury remains controversial. This study aimed to evaluate MAFLD effects on the chronic kidney disease (CKD) frequency The association between metabolic dysfunction associated fatty liver disease (MAFlD) and extrahepatic disease is not known .the aim of this cross sectional study is to compare the frequency of CKD in patients with MAFLD and examine association between presence and severity of MAFLD and CKD and abnormal albuminuria.
Non-alcoholic fatty liver disease (NAFLD) is characterized by the accumulation of fat in more than 5% of hepatocytes in the absence of excessive alcohol consumption and other secondary causes of hepatic steatosis. In 2020, the more inclusive term metabolic (dysfunction)-associated fatty liver disease (MAFLD) - defined by broader diagnostic criteria - was proposed to replace the term NAFLD. The new terminology and revised definition better emphasize the pathogenic role of metabolic dysfunction and uses a set of definitive, inclusive criteria for diagnosis. Diagnosis of MAFLD is based on evidence of hepatic steatosis (as assessed by liver biopsy, imaging techniques or blood biomarkers and scores) in persons who are overweight or obese and have type 2 diabetes mellitus or metabolic dysregulation, regardless of the coexistence of other liver diseases or excessive alcohol consumption.
The known association between NAFLD and chronic kidney disease (CKD) and our understanding that CKD can occur as a consequence of metabolic dysfunction suggests that individuals with MAFLD - who by definition have fatty liver and metabolic comorbidities - are at increased risk of CKD.
MAFLD appears to be tightly linked to incident chronic kidney disease (CKD). This association may be attributed to multiple shared risk factors including type 2 diabetes mellitus, arterial hypertension, obesity, dyslipidemia, and insulin resistance Diagnostic criteria of MAFLD are ( steatosis with one of the following
- BMI >25
- type II DM
- > 2 metabolic abnormalities [ 1)waist circumferance >94 in males or 80 in females 2)bp >130/85 3) plasma triglycrides > 150 mg / dl 4) HDL < 40 5)prediabetes 6) HOMA insulin resistance score >2.5 7)plasma hs CRP> 2 mg/dl ]
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the study is done on 150 patients diagnosed as MAFLD with its diagnostic criteria (Diagnostic criteria of MAFLD are ( steatosis with one of the following 1. BMI >25 2. type II DM 3. > 2 metabolic abnormalities [ 1)waist circumferance >94 in males or 80 in females 2)bp >130/85 3) plasma triglycrides > 150 mg / dl 4) HDL < 40 5)prediabetes 6) HOMA insulin resistance score >2.5 7)plasma hs CRP> 2 mg/dl ]. And divided into 3 groups : 1. MAFLD with type II DM 2. MAFLD not type II DM 3. control group
Key inclusion criteria (3 listed)
- CKD patients type II . III and type IV not on dialysis
- Patients with MAFLD
- patients with type II DM
Key exclusion criteria (8 listed)
- Patients with AKI
- patients with NAFLD
- patients with alcoholic fatty liver disease
- patients with type I DM
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the frequency of MAFLD in CKD patients 2_To screen early MAFLD in CKD patients 3_To association between MAFLD in CKD and type II DM patients
Time frame: Baseline
estimate the frequency of MAFLD in CKD patients 2_To screen early MAFLD in CKD patients 3_To association between MAFLD in CKD and type II DM patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mafld in Ckd Patients, run by Assiut University.
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 8 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
the frequency of MAFLD in CKD patients 2_To screen early MAFLD in CKD patients 3_To association between MAFLD in CKD and type II DM patients (time frame: Baseline). 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 18 Nov 2023.