NCT06357052

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. In order to study the association between NAFLD and nephrolithiasis while minimizing the confounding effect of metabolic syndrome, we investigated the impact of different degrees of NAFLD severity on potential risk factors for stone formation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Typical duration 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

Study Start

First participant enrolled

July 19, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

April 4, 2024

Last Update Submit

April 4, 2024

Conditions

NAFLDUrinary Lithiasis

Outcome Measures

Primary Outcomes (1)

  • the analysis of the correlation between the degree of severity of NAFLD And urinary lithogenic profilecharacterized by reduced urinary magnesium and altered urinary ammonium excretion.

    15 years

Study Arms (3)

NAFLD patients without liver cirrhosis (NLCs, n = 28)

NAFLD patients with liver cirrhosis (LCs, n = 14)

healthy individuals (HIs, n = 12)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 subjects suffering from NAFLD histologically ascertained by routine liver biopsy performed at the P.O. liver surgeries Columbus relating to the Gastroenterology Area Units.

You may qualify if:

  • subject \>= 18 years old
  • able to sign the ICF
  • Liver biopsy with report compatible with NAFLD

You may not qualify if:

  • alchol use \> 20g/die
  • other causes of liver disease
  • active neoplasm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico A.Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseUrolithiasis

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

July 19, 2019

Primary Completion

April 30, 2022

Study Completion

November 30, 2022

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

IT(1)