The Study of Lithogenesis Processes in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

NCT ID: NCT06357052

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-19

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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NAFLD Urinary Lithiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

healthy individuals (HIs, n = 12)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* alchol use \> 20g/die
* other causes of liver disease
* active neoplasm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Policlinico A.Gemelli IRCCS

Roma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2701

Identifier Type: -

Identifier Source: org_study_id

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