## Protocol Section
### Identification Module
**NCT ID:** NCT06433388

**Brief Title:** Perirenal Fats of Chronic Kidney Disease in Patients With Fatty Liver Disease.

**Official Title:** Perirenal Fats of Chronic Kidney Disease in Patients With Fatty Liver Disease.

#### Organization Study ID Info
**ID:** perirenal fats of ckd
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Aml Ahmed Ramadan Mohamed

**Investigator Title:** Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Chronic Kidney Diseases

- Fatty Liver

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 70

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Year

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 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

**Name:** MRI

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Association 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.

**Measure:** Perirenal fat thickness, as measured by MRI and PAUS and its relation to poor renal outcomes in chronic kidney diseased patient with Fatty liver disease.

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** aml375090@gmail.com

**Name:** Aml Ahmed Ramadan, Master

**Phone:** +201024485855

**Role:** CONTACT

**Contact 2:**

**Email:** samirkotb45@yahoo.com

**Name:** Samir Kamal Abdul_Hamid

**Phone:** +201062949199

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** professor

**Name:** Samir Kamal Abdul_Hamid, prof

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** 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:** 28218263

**Citation:** 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:** 35432188

**Citation:** 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:** 17699463

**Citation:** 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:** 24115475

**Citation:** 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:** 14757614

**Citation:** 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:** 18440683

**Citation:** 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:** 21712852

**Citation:** 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:** 32839279

**Citation:** 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:** 33460786

**Citation:** 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:** 25920090

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Kidney Disease

- ID: M11107

- Name: Liver Diseases

- Relevance: HIGH

- As Found: Liver Disease

- ID: M8375

- Name: Fatty Liver

- Relevance: HIGH

- As Found: Fatty Liver

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: HIGH

- As Found: Chronic Kidney Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T5868

- Name: Visceral Steatosis

- Relevance: HIGH

- As Found: Fatty Liver

### Condition Browse Module - Meshes

- ID: D000008107

- Term: Liver Diseases

- ID: D000005234

- Term: Fatty Liver

- ID: D000007674

- Term: Kidney Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
