Perirenal Fats of Chronic Kidney Disease in Patients With Fatty Liver Disease.

July 21, 2024 updated by: Aml Ahmed Ramadan Mohamed, Assiut University
Exploring the association of perirenal fat thickness assessed by MRI in CKD patients with FLD.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Age more than 18 years old regardless of gender

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Samir Kamal Abdul_Hamid, prof, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 21, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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