Fatty Liver DiseaseNCT06691529
Metabolic Associated Fatty Liver Disease in Patients With Chronic Glomerular Disease
An observational study of Fatty Liver Disease and Chronic Glomerular Disease, run by Assiut University.
Trial summary
The association of metabolic associated fatty liver disease in patients with chronic glomerular disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatty Liver Disease, Chronic Glomerular Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients in this study will be subjected to 1. Detailed history and full clinical examination 2. Anthropometric measurements; Hight, weight, waist circumference. 3. Full lab investigations (Complete blood picture , kidney function tests, liver function tests, serum electrolytes, Ferritin, Uric acid level, Prothrombin time and concentration and serum albumin) 4. High sensitivity CRP 5. lipid profile (Fasting) 6. urine analysis, ACR. 7. Available documented renal biopsy 8. HBA1c 9. C- peptide levels. 10. FIB4 - score
Who may be able to join
- All CKD patient aging between (18-70) years with known tubule-glomerular diseases.
- At any eGFR.
- All CKD patient have either type I/II DM associated with CKD .
Who cannot join
- CKD patients of Unknown etiology.
- CKD patients with liver cirrhosis.
- CKD patients secondry to documented diabetic nephropathy.
- Patients with previous/current HBV or HCV.
- Pregnant CKD patients.
- Patient commencing any hepatotoxic medication.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Association of Metabolic Associated Fatty Liver Disease in Patients With Chronic Glomerular Disease
The association of metabolic associated fatty liver disease in patients with chronic glomerular disease
Read the detailed description
Chronic kidney disease (CKD) is associated with high morbidity and mortality, and is rapidly becoming a major burden to the global health care system.
Chronic kidney disease CKD is a complex, progressive chronic condition that is defined by either abnormality of kidney structure or function present for ≥3 months Either markers of kidney damage or decreased glomerular filtration rate may be present.
The global prevalence of CKD was estimated at 10.4-13.4% , stage 5 HD is rapidly increasing worldwide and expected to further increase in the next decade .
Metabolic associated fatty liver disease (MAFLD) is characterized by excessive hepatic fat accumulation without significant alcohol intake, use of medications causing fatty liver, or other traditional causes of fatty liver, is the most common cause of chronic liver disease worldwide, especially in developed countries . MFLD refers to a wide spectrum of liver damage, ranging from simple steatosis to non-alcoholic steatohepatitis, advanced fibrosis and cirrhosis Studies have shown that MAFLD is the underlying cause of an increasing number of extrahepatic manifestations. MAFLD is mainly linked to type II diabetes mellitus (T2DM) and cardiovascular disease (CVD), as well as a number of other severe chronic diseases including chronic kidney disease (CKD) The diagnosis of MAFLD requires the presence of hepatic steatosis plus at least one of the following three metabolic risk abnormalities: overweight/obesity, T2DM or evidence of metabolic dysregulation.
Metabolic syndrome (MetS) was defined according to the National Cholesterol Education Program ATP III criteria (16) as the presence of any three or more of the following metabolic conditions: Abdominal obesity, waist circumference ⩾ 102 cm in men and ⩾ 88 cm in women. Serum triglycerides (TG) ⩾ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides, serum high-density lipoprotein cholesterol<40 mg/dL (1.0 mmol/L) in men and<50 mg/dL (1.3 mmol/L) in women or drug treatment for low high density lipoprotein cholesterol. Blood pressure ⩾ 130/85 mmHg or drug treatment for elevated blood pressure, fasting blood glucose ⩾ 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose.
Diabetes mellitus (DM) was defned as a fasting blood glucose level of ⩾125 mg/dl, or prescription of antidiabetic drugs, Hypertension was defned as systolic blood pressure (SBP) ⩾ 130 mmHg, diastolic blood pressure (DBP) ⩾ 85 mmg , or prescription of antihypertensive drugs.
A recent meta-analysis of about 10 million individuals reported a global prevalence of MAFLD of 38.8% in adults. In addition, it has been reported that MAFLD may progress to cirrhosis and promote the development of some important extrahepatic diseases, such as cardiovascular disease and chronic kidney disease (CKD).
MAFLD and CKD share some common features, including visceral obesity, T2DM, hypertension and metabolic syndrome and both diseases are also linked to an increased risk of CVD . Both diseases are progressive chronic conditions that represent a spectrum of diseases extending from relatively mild disease, with only modest changes in function, to severe debilitating disease with end-stage organ damage, necessitating either chronic dialysis or organ transplantation in order to sustain life.
The potential relationship between NAFLD and CKD has recently attracted scientists' interest. Establishing a relationship between liver and kidney injury would help to identify kidney illness sooner and enable for the selection of medicines that target both liver and kidney disease, with potentially beneficial preventative and therapeutic implications .
- Conditions
- Fatty Liver Disease, Chronic Glomerular Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | 500 patients presented at Nephrology unit/Internal Medicine department (Assiut University Hospital) In the period 2024-2026. |
What is being measured
The primary outcome is the main question the study is designed to answer.
association between metabolic associated fatty liver disease and chronic kidney disease
To detect the association between metabolic associated fatty liver disease and chronic kidney disease with glomerular diseaese in Assuit university hospital.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Fahmy Amin Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691529
- Sponsor's protocol ID
- fatty liver disease
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Metabolic Associated Fatty Liver Disease in Patients With Chronic Glomerular Disease
- ClinicalTrials.gov ID
- NCT06691529
- Acronym / sponsor ID
- fatty liver disease
- Conditions
- Fatty Liver Disease, Chronic Glomerular Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 15 Nov 2024 (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 association of metabolic associated fatty liver disease in patients with chronic glomerular disease
Detailed description
Chronic kidney disease (CKD) is associated with high morbidity and mortality, and is rapidly becoming a major burden to the global health care system.
Chronic kidney disease CKD is a complex, progressive chronic condition that is defined by either abnormality of kidney structure or function present for ≥3 months Either markers of kidney damage or decreased glomerular filtration rate may be present.
The global prevalence of CKD was estimated at 10.4-13.4% , stage 5 HD is rapidly increasing worldwide and expected to further increase in the next decade .
Metabolic associated fatty liver disease (MAFLD) is characterized by excessive hepatic fat accumulation without significant alcohol intake, use of medications causing fatty liver, or other traditional causes of fatty liver, is the most common cause of chronic liver disease worldwide, especially in developed countries . MFLD refers to a wide spectrum of liver damage, ranging from simple steatosis to non-alcoholic steatohepatitis, advanced fibrosis and cirrhosis Studies have shown that MAFLD is the underlying cause of an increasing number of extrahepatic manifestations. MAFLD is mainly linked to type II diabetes mellitus (T2DM) and cardiovascular disease (CVD), as well as a number of other severe chronic diseases including chronic kidney disease (CKD) The diagnosis of MAFLD requires the presence of hepatic steatosis plus at least one of the following three metabolic risk abnormalities: overweight/obesity, T2DM or evidence of metabolic dysregulation.
Metabolic syndrome (MetS) was defined according to the National Cholesterol Education Program ATP III criteria (16) as the presence of any three or more of the following metabolic conditions: Abdominal obesity, waist circumference ⩾ 102 cm in men and ⩾ 88 cm in women. Serum triglycerides (TG) ⩾ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides, serum high-density lipoprotein cholesterol<40 mg/dL (1.0 mmol/L) in men and<50 mg/dL (1.3 mmol/L) in women or drug treatment for low high density lipoprotein cholesterol. Blood pressure ⩾ 130/85 mmHg or drug treatment for elevated blood pressure, fasting blood glucose ⩾ 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose.
Diabetes mellitus (DM) was defned as a fasting blood glucose level of ⩾125 mg/dl, or prescription of antidiabetic drugs, Hypertension was defned as systolic blood pressure (SBP) ⩾ 130 mmHg, diastolic blood pressure (DBP) ⩾ 85 mmg , or prescription of antihypertensive drugs.
A recent meta-analysis of about 10 million individuals reported a global prevalence of MAFLD of 38.8% in adults. In addition, it has been reported that MAFLD may progress to cirrhosis and promote the development of some important extrahepatic diseases, such as cardiovascular disease and chronic kidney disease (CKD).
MAFLD and CKD share some common features, including visceral obesity, T2DM, hypertension and metabolic syndrome and both diseases are also linked to an increased risk of CVD . Both diseases are progressive chronic conditions that represent a spectrum of diseases extending from relatively mild disease, with only modest changes in function, to severe debilitating disease with end-stage organ damage, necessitating either chronic dialysis or organ transplantation in order to sustain life.
The potential relationship between NAFLD and CKD has recently attracted scientists' interest. Establishing a relationship between liver and kidney injury would help to identify kidney illness sooner and enable for the selection of medicines that target both liver and kidney disease, with potentially beneficial preventative and therapeutic implications .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –500 patients presented at Nephrology unit/Internal Medicine department (Assiut University Hospital) In the period 2024-2026. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in this study will be subjected to 1. Detailed history and full clinical examination 2. Anthropometric measurements; Hight, weight, waist circumference. 3. Full lab investigations (Complete blood picture , kidney function tests, liver function tests, serum electrolytes, Ferritin, Uric acid level, Prothrombin time and concentration and serum albumin) 4. High sensitivity CRP 5. lipid profile (Fasting) 6. urine analysis, ACR. 7. Available documented renal biopsy 8. HBA1c 9. C- peptide levels. 10. FIB4 - score
Key inclusion criteria (3 listed)
- All CKD patient aging between (18-70) years with known tubule-glomerular diseases.
- At any eGFR.
- All CKD patient have either type I/II DM associated with CKD .
Key exclusion criteria (6 listed)
- CKD patients of Unknown etiology.
- CKD patients with liver cirrhosis.
- CKD patients secondry to documented diabetic nephropathy.
- Patients with previous/current HBV or HCV.
- Pregnant CKD patients.
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
association between metabolic associated fatty liver disease and chronic kidney disease
Time frame: through study completion, an average of 1 year
To detect the association between metabolic associated fatty liver disease and chronic kidney disease with glomerular diseaese in Assuit university hospital.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver Disease and Chronic Glomerular Disease, 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 6 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: opening soon, as of the sponsor's last update on 18 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samar Fahmy Amin (01004084187, elamin67@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between metabolic associated fatty liver disease and chronic kidney disease (time frame: through study completion, an average of 1 year). 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 2024.