NCT05556135

Brief Summary

Early detection of renal impairment in patients with Non-alcoholic fatty liver disease and its correlation with serum Adiponectin level.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

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

September 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 23, 2022

Last Update Submit

September 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlate serum Adiponectin level with renal impairment in non-alcoholic fatty liver disease.

    Correlate serum Adiponectin level with renal impairment in non-alcoholic fatty liver disease. /

    baseline

Study Arms (2)

group1

NAFLD patients

Diagnostic Test: level of serun adiponectin

group 2

non NAFLD patients

Diagnostic Test: level of serun adiponectin

Interventions

estimation of level of serum adiponectin in NAFLD for early detection of renal impairement

group 2group1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients who fulfil inclusion and exclusion criteria then directed to nephrology unit to do other full investigations ,will be included in this study . 1)Full history and clinical examination .2) Investigation : * All patients will be investigated for detection of renal impairment by : 1)microalbuminurea. * 2)Urine analyses. * 3)Kidney function tests. * 4)calculate GFR. * 5)Complete blood count . * And also to detect the degree of liver affection by: * 1)liver function tests . * 2)abdominal ultrasound to grade fatty liver \& determine echogenicity of kidney . * 3)Non-invasive blood test to detect degree of hepatic steatosis ( FIB-4 , APRI, fibrosis score ). 4)fibroscane . * Detection of serum Adiponectin by ELISA technique using (EIA-3418) KIT, DRG international inc., USA \*Investigations to control risk factors of Non-alcoholic fatty liver disease: -Calculate Body Mass Index (BMI). - Measuring the fasting blood sugar and HbA1C level in all subjects. -Lipid Profile.

You may qualify if:

  • Patients with fatty liver aged from 18 to 60 yrs either diabetic or not .
  • Patient with normal echogenic kidney in ultrasound and eGFR more than 60 mL/min/1.73m2.
  • The Control group are completely healthy subjects without any systemic or liver and kidney affection

You may not qualify if:

  • )Patients less than 18 yrs \& more than 60 yrs 2)All patients having any other causes of renal and hepatic disease rather than Diabetes and having any other systemic problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Montesano R, Orci L, Vassalli P. In vitro rapid organization of endothelial cells into capillary-like networks is promoted by collagen matrices. J Cell Biol. 1983 Nov;97(5 Pt 1):1648-52. doi: 10.1083/jcb.97.5.1648.

    PMID: 6630296BACKGROUND
  • Stefan N, Stumvoll M. Adiponectin--its role in metabolism and beyond. Horm Metab Res. 2002 Sep;34(9):469-74. doi: 10.1055/s-2002-34785.

    PMID: 12384822BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • mohamed hassan, MD

    master

    STUDY DIRECTOR

Central Study Contacts

Mustafa Abdelrafie, master

CONTACT

mohamed elyamany, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
mohamed elyamany

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 27, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

September 27, 2022

Record last verified: 2022-09