NCT03172650

Brief Summary

Non-alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. It is defined as the accumulation of fat (\>5%) in the liver cells in the absence of excessive alcohol intake or other causes of liver disease including viral, drug-induced, or autoimmune. Non-alcoholic fatty liver disease is a hepatic manifestation of metabolic syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

May 30, 2017

Last Update Submit

August 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with abnormal laboratory glomerular filtration rate

    decreased glomerular filtration rate \<60 mL/minute will be considered abnormal

    1 day

Study Arms (2)

study group

non alcoholic fatty liver disease patients

Diagnostic Test: glomerular filtration rate

Control group

fatty liver patients

Diagnostic Test: glomerular filtration rate

Interventions

collection of blood sample 5 milliliter for calculation of glomerular filtration rate

Control groupstudy group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be recruited outpatient clinic of internal medicine of Luxor international hospital and Assiut university hospital

You may qualify if:

  • All non alcoholic fatty liver disease patients evidenced by abdominal ultrasound.
  • Urine analysis whether normal or renal sedimentation.

You may not qualify if:

  • Alcoholic fatty liver patients.
  • patients known to have diabetes mellitus.
  • patients with other causes of liver disease as viral hepatitis, drug induced,or autoimmune.
  • patients known to have kidney disease.
  • Hypertension.
  • Hyperuricemia.
  • Impaired urea and creatinine patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Interventions

Glomerular Filtration Rate

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Kidney Function TestsDiagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosisUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Central Study Contacts

Mahmoud Ali, MBBCh

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

August 16, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations