Assessment of Renal Changes in Patients With Non Alcoholic Fatty Liver Disease

NCT03487068 | Unknown

• 1 other identifier: Renal changes with NAFLD
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assess the renal changes in patients with non-alcoholic fatty liver (NAFLD).

Conditions

Non-Alcoholic Fatty Liver Disease; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Assessment of renal changes in patients with non-alcoholic fatty liver disease

  Measuring renal changes especially glomerular and interstitial pathologies which will lead to chronic kidney disease in patients with non alcoholic fatty liver disease.

  baseline

Study Arms (1)

Patients with NAFLD

OTHER

Device: The FibroScan device

Interventions

The FibroScan device DEVICE

The Fibroscan device (Echosens) works by measuring shear wave velocity. In this technique, a 50-MHz wave is passed into the liver from a small transducer on the end of an ultrasound probe. The probe also has a transducer on the end that can measure the velocity of the shear wave (in meters per second) as this wave passes through the liver. The shear wave velocity can then be converted into liver stiffness, which is expressed in kilopascals. Essentially, the technology measures the velocity of the sound wave passing through the liver and then converts that measurement into a liver stiffness measurement; the entire process is often referred to as liver ultrasonographic elastography.

Patients with NAFLD

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed as NAFLD by abdominal ultrasonography, Fibroscan, NAFLD fibrosis score and FIB-4 score

You may not qualify if:

• Patients with diabetes and/or hypertension.
• Patients with chronic renal disease.
• Patients with urinary tract infections.
• Patients on medications affecting the kidney (eg: NSAIDs,..etc)
• Patients with chronic liver disease other than NAFLD (chronic hepatitis; viral B,C, autoimmune etc).
• Alcohol consumption.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Castera L. Diagnosis of non-alcoholic fatty liver disease/non-alcoholic steatohepatitis: Non-invasive tests are enough. Liver Int. 2018 Feb;38 Suppl 1:67-70. doi: 10.1111/liv.13658.

  PMID: 29427494 BACKGROUND

• Sinn DH, Kang D, Jang HR, Gu S, Cho SJ, Paik SW, Ryu S, Chang Y, Lazo M, Guallar E, Cho J, Gwak GY. Development of chronic kidney disease in patients with non-alcoholic fatty liver disease: A cohort study. J Hepatol. 2017 Dec;67(6):1274-1280. doi: 10.1016/j.jhep.2017.08.024. Epub 2017 Sep 20.

  PMID: 28870674 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maiada M Ibrahim, Master

CONTACT

01068388643; maiada145@yahoo.com

Mohamed El Taher, PHD

CONTACT

01005602251; Mohamedeltaheribrahim@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor Of Gastroenterology

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 3, 2018
• Study Start: April 30, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 30, 2019
• Last Updated: April 4, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share