NCT04779905

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide. This disease reportedly affects up to 30% of the general population in Western countries, especially in patients with metabolic syndrome, obesity, and type II diabetes. NAFLD is considered to be an independent risk factor for cardiovascular disease and there is accumulating evidence to support a causative role in the development of chronic kidney disease (CKD). So, we aim first to assess the prevalence of chronic kidney disease in NAFLD patients, secondly to detect the association between hepatic fibrosis and CKD in NAFLD patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 26, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

February 28, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

November 2, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

February 26, 2021

Last Update Submit

November 1, 2021

Conditions

Keywords

chronic kidney diseaseNAFLDHepatic fibrosis

Outcome Measures

Primary Outcomes (2)

  • prevalence of chronic kidney disease in nafld patient

    February 2021 to July 2021

  • correlation of chronic kidney disease and degree of hepatic fibrosis in nafld patient

    February 2021 to July 2021

Study Arms (2)

Non-alcoholic Fatty Liver Diseases

patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital

Diagnostic Test: urinary albumbin/creatinine ratio

control

healthy volunteers who looks normal on ultrasonography

Diagnostic Test: urinary albumbin/creatinine ratio

Interventions

detection of microalbuminuria in nafld patients

Also known as: estimated glomerular filtration rate
Non-alcoholic Fatty Liver Diseasescontrol

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will be conducted on 100 patients 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital, and A control group of 30 healthy volunteers who looks normal on ultrasonography from February 2021 to July 2021

You may qualify if:

  • patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital

You may not qualify if:

  • Diabetic patients.
  • Hypertensive patients.
  • Other causes of chronic liver disease rather than NAFLD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mona Mohammed Abdelrahman

Sohag, Egypt

Location

Related Publications (4)

  • Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30.

    PMID: 21623852BACKGROUND
  • Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.

    PMID: 22488764BACKGROUND
  • Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.

    PMID: 24042449BACKGROUND
  • 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: 21965592BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicNon-alcoholic Fatty Liver DiseaseLiver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Radwa Farag, MD

    Sohag University

    STUDY CHAIR
  • Mohamed Amin, MD

    Sohag University

    STUDY CHAIR
  • Shimaa Hemdan, MD

    Sohag University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 3, 2021

Study Start

February 28, 2021

Primary Completion

July 30, 2021

Study Completion

September 15, 2021

Last Updated

November 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations