Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut University Hospitals

NCT04482153 | Unknown

• 1 other identifier: NAFLD inCKD
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of our study is:

1. 1.The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.
2. 2.Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.

Conditions

Study of the NAFLD in CKD Patients Using Fibroscan Study

Outcome Measures

Primary Outcomes (2)

• The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.

  The early detection of NAFLD in CKD patients with different stages (stage I to IV) to avoid progression to liver fibrosis.

  1 year

• Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.

  Evaluation of the relationship between the severity of fatty liver in NAFLD assessed by liver enzymes, biochemical markers, ultrasonography and grades of Fibroscan with CKD staging, eGFR and proteinuria.

  1year

Interventions

fibroscan DEVICE

The Controlled Attenuation Parameter (CAP) can using transient elastography (TE) (Fibroscan®) permits to efficiently separate different grades of severity of steatosis. CAP is based on the properties of ultrasonic signals acquired by the Fibroscan®. It allows to simultaneously measure liver stiffness and CAP in the same liver volume.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eighty CKD patients with different stages (stage I to IV) according to the National Kidney Foundation are recruited from inpatients of renal unit in internal medicine department, Assuit university hospitals. Their GFR will assessed by using CKD EPI

You may qualify if:

• \- Eighty CKD patients with different stages (stage I to IV) according to the National Kidney Foundation are recruited from inpatients of renal unit in internal medicine department, Assuit university hospitals. Their GFR will assessed by using CKD EPI equation measured as GFR=166 x(s cr/0.7)-1.209X(0.993)age if female, and GFR=163X(s cr/0.9)-1.209x(0.993)age if male. (Andrews et al 2009).
• CKD staging according to GFR by CKD EPI is:
• Stage1 in which GFR\>90 mil/min but evidence of kidney damage.
• Stage 2 GFR 60-89 mil/min.
• Stage 3 GFR 30-95 mil/min.
• Stage 4 GFR 15-29 mil/min.
• Stage 5 GFR\<15 mil/min. The patients will be enrolled from October 2020 to October 2021.

You may not qualify if:

• All Patients with positive hepatitis C virus antibodies. 2- All Patients with positive hepatitis B surface antigen. 3- Congested liver. 4- Drug induced hepatosteatosis (INH, estrogens, methotrexate, steroids, amiodarone, etc.).
• Autoimmune liver diseases. 6- Metabolic liver diseases. 7- Alcoholic liver disease. 8- Malignancy. 9- ESRD (stage V) on hemodialysis. 10- Obesity overweight BMI \> 30. 11- Metabolic syndrome. 12- Type II DM.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (11)

• Dowman JK, Tomlinson JW, Newsome PN. Systematic review: the diagnosis and staging of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2011 Mar;33(5):525-40. doi: 10.1111/j.1365-2036.2010.04556.x. Epub 2010 Dec 29.

  PMID: 21198708 BACKGROUND

• Guha IN, Parkes J, Roderick P, Chattopadhyay D, Cross R, Harris S, Kaye P, Burt AD, Ryder SD, Aithal GP, Day CP, Rosenberg WM. Noninvasive markers of fibrosis in nonalcoholic fatty liver disease: Validating the European Liver Fibrosis Panel and exploring simple markers. Hepatology. 2008 Feb;47(2):455-60. doi: 10.1002/hep.21984.

  PMID: 18038452 BACKGROUND

• Hamad AA, Khalil AA, Connolly V, Ahmed MH. Relationship between non-alcoholic fatty liver disease and kidney function: a communication between two organs that needs further exploration. Arab J Gastroenterol. 2012 Dec;13(4):161-5. doi: 10.1016/j.ajg.2012.06.010. Epub 2012 Sep 10.

  PMID: 23432982 BACKGROUND

• Ikizler TA. CKD classification: time to move beyond KDOQI. J Am Soc Nephrol. 2009 May;20(5):929-30. doi: 10.1681/ASN.2009030309. Epub 2009 Apr 23. No abstract available.

  PMID: 19389841 BACKGROUND

• Kiapidou S, Liava C, Kalogirou M, Akriviadis E, Sinakos E. Chronic kidney disease in patients with non-alcoholic fatty liver disease: What the Hepatologist should know? Ann Hepatol. 2020 Mar-Apr;19(2):134-144. doi: 10.1016/j.aohep.2019.07.013. Epub 2019 Sep 23.

  PMID: 31606352 BACKGROUND

• Martinez SM, Crespo G, Navasa M, Forns X. Noninvasive assessment of liver fibrosis. Hepatology. 2011 Jan;53(1):325-35. doi: 10.1002/hep.24013. Epub 2010 Nov 29.

  PMID: 21254180 BACKGROUND

• McCullough K, Sharma P, Ali T, Khan I, Smith WC, MacLeod A, Black C. Measuring the population burden of chronic kidney disease: a systematic literature review of the estimated prevalence of impaired kidney function. Nephrol Dial Transplant. 2012 May;27(5):1812-21. doi: 10.1093/ndt/gfr547. Epub 2011 Sep 29.

  PMID: 21965592 BACKGROUND

• Shah B, Sucher K, Hollenbeck CB. Comparison of ideal body weight equations and published height-weight tables with body mass index tables for healthy adults in the United States. Nutr Clin Pract. 2006 Jun;21(3):312-9. doi: 10.1177/0115426506021003312.

  PMID: 16772549 BACKGROUND

• Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.

  PMID: 23732715 BACKGROUND

• Thomas G, Sehgal AR, Kashyap SR, Srinivas TR, Kirwan JP, Navaneethan SD. Metabolic syndrome and kidney disease: a systematic review and meta-analysis. Clin J Am Soc Nephrol. 2011 Oct;6(10):2364-73. doi: 10.2215/CJN.02180311. Epub 2011 Aug 18.

  PMID: 21852664 BACKGROUND

• Yasui K, Sumida Y, Mori Y, Mitsuyoshi H, Minami M, Itoh Y, Kanemasa K, Matsubara H, Okanoue T, Yoshikawa T. Nonalcoholic steatohepatitis and increased risk of chronic kidney disease. Metabolism. 2011 May;60(5):735-9. doi: 10.1016/j.metabol.2010.07.022. Epub 2010 Sep 3.

  PMID: 20817213 BACKGROUND

Central Study Contacts

marwa ahmed, resident doctor

CONTACT

01140291416; marwa011398@med.au.edu.eg

effat tony, proffessor

CONTACT

01097330309; effattony@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 22, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 22, 2020

Record last verified: 2020-07