NCT06433388

Brief Summary

Exploring the association of perirenal fat thickness assessed by MRI in CKD patients with FLD.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

May 22, 2024

Last Update Submit

July 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from the out-patient clinics of the Internal Medicine Department, Assiut university

You may qualify if:

  • Age more than 18 years old regardless of gender

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 28218263BACKGROUND
  • Zhang 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.

    PMID: 35432188BACKGROUND
  • Wahba 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.

    PMID: 17699463BACKGROUND
  • Stenvinkel 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.

    PMID: 24115475BACKGROUND
  • Chen 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.

    PMID: 14757614BACKGROUND
  • Sanches 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.

    PMID: 18440683BACKGROUND
  • Levin 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.

    PMID: 21712852BACKGROUND
  • Tonelli 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.

    PMID: 32839279BACKGROUND
  • Ajmera 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.

    PMID: 33460786BACKGROUND
  • Byrne CD, Targher G. NAFLD: a multisystem disease. J Hepatol. 2015 Apr;62(1 Suppl):S47-64. doi: 10.1016/j.jhep.2014.12.012.

    PMID: 25920090BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicFatty Liver

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Officials

  • Samir Kamal Abdul_Hamid, prof

    professor

    STUDY DIRECTOR

Central Study Contacts

Aml Ahmed Ramadan, Master

CONTACT

Samir Kamal Abdul_Hamid

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 22, 2024

First Posted

May 29, 2024

Study Start

August 1, 2024

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

July 23, 2024

Record last verified: 2024-07