Chronic Kidney DiseasesNCT06433388
Perirenal Fats of Chronic Kidney Disease in Patients With Fatty Liver Disease.
An observational study of Chronic Kidney Diseases and Fatty Liver, run by Assiut University.
Trial summary
Exploring the association of perirenal fat thickness assessed by MRI in CKD patients with FLD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Fatty Liver
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Sep 2025
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the out-patient clinics of the Internal Medicine Department, Assiut university
Who may be able to join
- Age more than 18 years old regardless of gender
Who cannot join
- Other causes of chronic liver diseases (HCV, HBV...).
- End stage renal diseases (GFR<15 ml/min).
- A history of significant alcohol intake (>20 g/day in females and 30 g/day in males).
- Those using medications that can cause fatty liver.
- Pregnant patients.
Trial locations and contacts
No sites are listed yet.
About this study
Exploring the association of perirenal fat thickness assessed by MRI in CKD patients with FLD.
Read the detailed description
Fatty liver disease (FLD) is caused by an accumulation of excessive fat in the liver that leads to liver damage. It has been noticed that fatty liver disease affects not only liver diseases but also extra-hepatic organ systems such as the cardiovascular and renal systems. Increasing the prevalence of FLD has a great association with increasing the risk of cardiovascular diseases, chronic kidney diseases, and Type 2 diabetes mellitus. Hypertension, insulin resistance, and abdominal obesity are risk factors that are shared by FLD and CKD. Moreover, patients with CKD have a great prevalence of developing FLD, and CKD incidence is increased by the presence of FLD.
Obesity is one of the most comorbidities over the world, it is related and increase the risk of cardio metabolic disease, as well as it is a strong risk factor for chronic kidney disease (CKD), and the prevalence of both conditions is rising worldwide, Several recent epidemiologic studies have shown that obesity and the metabolic syndrome are independent predictors of CKD. The most common method for defining obesity is based on BMI(weight [kilograms] divided by the square of height [meters]).
previously abdominal fat distribution have been measured by BMI, waist to hip ratio (WHR), OR Waist circumference. Although waist circumference was noted to be a reliable predictor of visceral fat, many interfering factors may also reduce the reliability of WC in estimating abdominal fat deposition, as well as the associated risk for CKD like ageing and normal difference in fat distribution between the two genders. Based on these considerations, we presume that per renal fat thickness measurement by MRI may better reflect the risks commonly associated with increased visceral fat accumulation and particularly those related to renal function impairment.
Chronic kidney disease is defined as impairment or structural damage to kidney or kidney function. It manifested by reduction in estimated glomerular rate (eGFR) for at least 3 months. It presented with proteinuria or albuminuria, hematuria. The best diagnosis by biopsy showing renal impairment, or by imaging ultrasound. CKD associated with morbidity and mortality condition especially in developing countries, so it has been necessary to early detection to prevent CKD progression and associated complications, thus improving patient outcomes and reducing the impact of CKD on health-care resources.
FLD begins with liver lipid accumulation, and marked hepatic fat accumulation is a risk factor for disease progression. Liver biopsy is the golden for diagnosis and assessment of the severity of steatosis and grading of fibrosis, although being invasive and difficult method. Ultrasound and magnetic resonance imaging (MRI) biomarkers of liver fat Gives the advantage diagnose FLD as it is non-invasive imaging biomarkers to diagnose FLD, steatosis , and fibrosis.
Therefore the aim of this study is to determine the independent association of Perirenal fat assessment by MRI with the main markers of kidney function, such as estimated glomerular filtration rate (eGFR), albuminuria as well as with serum urate values on one side, and grading of fibrosis and steatosis in FLD patients on the other side.
- Conditions
- Chronic Kidney Diseases, Fatty Liver
- Being tested
- MRI
- Medical subject headings
- Renal Insufficiency, Chronic, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Magnetic Resonance Imaging (MRI) is a non-invasive imaging technology that produces three dimensional detailed anatomical images. Patients will be subjected to MRI scans and imaging of the kidneys and liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of increase perirenal fat thickness in CKD patients with fatty liver disease. Perirenal fat thickness measured by magnetic resonance imaging (MRI) and pelvic abdominal ultrasound (PAUS).
Correlation between perirenal fat thickness measured by MRI and PAUS and the main markers of kidney function, such as estimated glomerular filtration rate (eGFR), albuminuria and serum urate in CKD patient with FLD.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- 70 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Ahmed Ramadan Mohamed, Assiut University
- Investigators
- Samir Kamal Abdul_Hamid, prof, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433388
- Sponsor's protocol ID
- perirenal fats of ckd
- Status last verified
- Jul 2024
- First submitted
- 22 May 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Targher G, Byrne CD. Non-alcoholic fatty liver disease: an emerging driving force in chronic kidney disease. Nat Rev Nephrol. 2017 May;13(5):297-310. doi: 10.1038/nrneph.2017.16. Epub 2017 Feb 20.
PubMed 28218263Zhang QH, Xie LH, Zhang HN, Liu JH, Zhao Y, Chen LH, Ju Y, Chen AL, Wang N, Song QW, Xie LZ, Liu AL. Magnetic Resonance Imaging Assessment of Abdominal Ectopic Fat Deposition in Correlation With Cardiometabolic Risk Factors. Front Endocrinol (Lausanne). 2022 Mar 30;13:820023. doi: 10.3389/fendo.2022.820023. eCollection 2022.
PubMed 35432188Wahba IM, Mak RH. Obesity and obesity-initiated metabolic syndrome: mechanistic links to chronic kidney disease. Clin J Am Soc Nephrol. 2007 May;2(3):550-62. doi: 10.2215/CJN.04071206. Epub 2007 Mar 14.
PubMed 17699463Stenvinkel P, Zoccali C, Ikizler TA. Obesity in CKD--what should nephrologists know? J Am Soc Nephrol. 2013 Nov;24(11):1727-36. doi: 10.1681/ASN.2013040330. Epub 2013 Oct 10.
PubMed 24115475Chen J, Muntner P, Hamm LL, Jones DW, Batuman V, Fonseca V, Whelton PK, He J. The metabolic syndrome and chronic kidney disease in U.S. adults. Ann Intern Med. 2004 Feb 3;140(3):167-74. doi: 10.7326/0003-4819-140-3-200402030-00007.
PubMed 14757614Sanches FM, Avesani CM, Kamimura MA, Lemos MM, Axelsson J, Vasselai P, Draibe SA, Cuppari L. Waist circumference and visceral fat in CKD: a cross-sectional study. Am J Kidney Dis. 2008 Jul;52(1):66-73. doi: 10.1053/j.ajkd.2008.02.004. Epub 2008 Apr 28.
PubMed 18440683Levin A, Stevens PE. Early detection of CKD: the benefits, limitations and effects on prognosis. Nat Rev Nephrol. 2011 Jun 28;7(8):446-57. doi: 10.1038/nrneph.2011.86.
PubMed 21712852Tonelli M, Dickinson JA. Early Detection of CKD: Implications for Low-Income, Middle-Income, and High-Income Countries. J Am Soc Nephrol. 2020 Sep;31(9):1931-1940. doi: 10.1681/ASN.2020030277. Epub 2020 Aug 24.
PubMed 32839279Ajmera V, Loomba R. Imaging biomarkers of NAFLD, NASH, and fibrosis. Mol Metab. 2021 Aug;50:101167. doi: 10.1016/j.molmet.2021.101167. Epub 2021 Jan 15.
PubMed 33460786Byrne CD, Targher G. NAFLD: a multisystem disease. J Hepatol. 2015 Apr;62(1 Suppl):S47-64. doi: 10.1016/j.jhep.2014.12.012.
PubMed 25920090
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perirenal Fats of Chronic Kidney Disease in Patients With Fatty Liver Disease.
- ClinicalTrials.gov ID
- NCT06433388
- Acronym / sponsor ID
- perirenal fats of ckd
- Conditions
- Chronic Kidney Diseases, Fatty Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 29 May 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.
Exploring the association of perirenal fat thickness assessed by MRI in CKD patients with FLD.
Detailed description
Fatty liver disease (FLD) is caused by an accumulation of excessive fat in the liver that leads to liver damage. It has been noticed that fatty liver disease affects not only liver diseases but also extra-hepatic organ systems such as the cardiovascular and renal systems. Increasing the prevalence of FLD has a great association with increasing the risk of cardiovascular diseases, chronic kidney diseases, and Type 2 diabetes mellitus. Hypertension, insulin resistance, and abdominal obesity are risk factors that are shared by FLD and CKD. Moreover, patients with CKD have a great prevalence of developing FLD, and CKD incidence is increased by the presence of FLD.
Obesity is one of the most comorbidities over the world, it is related and increase the risk of cardio metabolic disease, as well as it is a strong risk factor for chronic kidney disease (CKD), and the prevalence of both conditions is rising worldwide, Several recent epidemiologic studies have shown that obesity and the metabolic syndrome are independent predictors of CKD. The most common method for defining obesity is based on BMI(weight [kilograms] divided by the square of height [meters]).
previously abdominal fat distribution have been measured by BMI, waist to hip ratio (WHR), OR Waist circumference. Although waist circumference was noted to be a reliable predictor of visceral fat, many interfering factors may also reduce the reliability of WC in estimating abdominal fat deposition, as well as the associated risk for CKD like ageing and normal difference in fat distribution between the two genders. Based on these considerations, we presume that per renal fat thickness measurement by MRI may better reflect the risks commonly associated with increased visceral fat accumulation and particularly those related to renal function impairment.
Chronic kidney disease is defined as impairment or structural damage to kidney or kidney function. It manifested by reduction in estimated glomerular rate (eGFR) for at least 3 months. It presented with proteinuria or albuminuria, hematuria. The best diagnosis by biopsy showing renal impairment, or by imaging ultrasound. CKD associated with morbidity and mortality condition especially in developing countries, so it has been necessary to early detection to prevent CKD progression and associated complications, thus improving patient outcomes and reducing the impact of CKD on health-care resources.
FLD begins with liver lipid accumulation, and marked hepatic fat accumulation is a risk factor for disease progression. Liver biopsy is the golden for diagnosis and assessment of the severity of steatosis and grading of fibrosis, although being invasive and difficult method. Ultrasound and magnetic resonance imaging (MRI) biomarkers of liver fat Gives the advantage diagnose FLD as it is non-invasive imaging biomarkers to diagnose FLD, steatosis , and fibrosis.
Therefore the aim of this study is to determine the independent association of Perirenal fat assessment by MRI with the main markers of kidney function, such as estimated glomerular filtration rate (eGFR), albuminuria as well as with serum urate values on one side, and grading of fibrosis and steatosis in FLD patients on the other side.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the out-patient clinics of the Internal Medicine Department, Assiut university
Key inclusion criteria (1 listed)
- Age more than 18 years old regardless of gender
Key exclusion criteria (5 listed)
- Other causes of chronic liver diseases (HCV, HBV...).
- End stage renal diseases (GFR<15 ml/min).
- A history of significant alcohol intake (>20 g/day in females and 30 g/day in males).
- Those using medications that can cause fatty liver.
- Pregnant patients.
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 |
|---|---|---|
| MRIMagnetic Resonance Imaging (MRI) is a non-invasive imaging technology that produces three dimensional detailed anatomical images. Patients will be subjected to MRI scans and imaging of the kidneys and liver | Device | – |
Primary outcome
Incidence of increase perirenal fat thickness in CKD patients with fatty liver disease. Perirenal fat thickness measured by magnetic resonance imaging (MRI) and pelvic abdominal ultrasound (PAUS).
Time frame: Baseline
Correlation between perirenal fat thickness measured by MRI and PAUS and the main markers of kidney function, such as estimated glomerular filtration rate (eGFR), albuminuria and serum urate in CKD patient with FLD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 28218263Targher G, Byrne CD. Non-alcoholic fatty liver disease: an emerging driving force in chronic kidney disease. Nat Rev Nephrol. 2017 May;13(5):297-310. doi: 10.1038/nrneph.2017.16. Epub 2017 Feb 20.
- Background: PubMed 35432188Zhang QH, Xie LH, Zhang HN, Liu JH, Zhao Y, Chen LH, Ju Y, Chen AL, Wang N, Song QW, Xie LZ, Liu AL. Magnetic Resonance Imaging Assessment of Abdominal Ectopic Fat Deposition in Correlation With Cardiometabolic Risk Factors. Front Endocrinol (Lausanne). 2022 Mar 30;13:820023. doi: 10.3389/fendo.2022.820023. eCollection 2022.
- Background: PubMed 17699463Wahba IM, Mak RH. Obesity and obesity-initiated metabolic syndrome: mechanistic links to chronic kidney disease. Clin J Am Soc Nephrol. 2007 May;2(3):550-62. doi: 10.2215/CJN.04071206. Epub 2007 Mar 14.
- Background: PubMed 24115475Stenvinkel P, Zoccali C, Ikizler TA. Obesity in CKD--what should nephrologists know? J Am Soc Nephrol. 2013 Nov;24(11):1727-36. doi: 10.1681/ASN.2013040330. Epub 2013 Oct 10.
- Background: PubMed 14757614Chen J, Muntner P, Hamm LL, Jones DW, Batuman V, Fonseca V, Whelton PK, He J. The metabolic syndrome and chronic kidney disease in U.S. adults. Ann Intern Med. 2004 Feb 3;140(3):167-74. doi: 10.7326/0003-4819-140-3-200402030-00007.
- Background: PubMed 18440683Sanches FM, Avesani CM, Kamimura MA, Lemos MM, Axelsson J, Vasselai P, Draibe SA, Cuppari L. Waist circumference and visceral fat in CKD: a cross-sectional study. Am J Kidney Dis. 2008 Jul;52(1):66-73. doi: 10.1053/j.ajkd.2008.02.004. Epub 2008 Apr 28.
- Background: PubMed 21712852Levin A, Stevens PE. Early detection of CKD: the benefits, limitations and effects on prognosis. Nat Rev Nephrol. 2011 Jun 28;7(8):446-57. doi: 10.1038/nrneph.2011.86.
- Background: PubMed 32839279Tonelli M, Dickinson JA. Early Detection of CKD: Implications for Low-Income, Middle-Income, and High-Income Countries. J Am Soc Nephrol. 2020 Sep;31(9):1931-1940. doi: 10.1681/ASN.2020030277. Epub 2020 Aug 24.
- Background: PubMed 33460786Ajmera V, Loomba R. Imaging biomarkers of NAFLD, NASH, and fibrosis. Mol Metab. 2021 Aug;50:101167. doi: 10.1016/j.molmet.2021.101167. Epub 2021 Jan 15.
- Background: PubMed 25920090Byrne CD, Targher G. NAFLD: a multisystem disease. J Hepatol. 2015 Apr;62(1 Suppl):S47-64. doi: 10.1016/j.jhep.2014.12.012.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Samir Kamal Abdul_Hamid, prof study director
professor
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Fatty Liver, 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 1 inclusion and 5 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 23 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aml Ahmed Ramadan, Master (+201024485855, aml375090@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of increase perirenal fat thickness in CKD patients with fatty liver disease. Perirenal fat thickness measured by magnetic resonance imaging (MRI) and pelvic abdominal ultrasound (PAUS). (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06433388, which also lists 10 linked publications.
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 23 Jul 2024.