Characterization of Hepatopathy in Turner Syndrome: Analysis of Determinants

NCT06794190 | Recruiting

• 1 other identifier: LIVER_TS-2023
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is therefore aimed at investigating the prevalence of hepatic alterations (laboratory and imaging) in adult patients with TS and generating hypothesissto the possible etiopathogenetic factors most involved, as well as evaluating the correlation between biochemical and structural abnormalities. Thus, the study could provide relevant etiopathogenetic and prognostic results on the development of hepatopathy in TS patients.

Conditions

Turner Syndrome

Outcome Measures

Primary Outcomes (1)

• Factors associated with hepatopathy

  Hepatopathy, defined as the presence of at least one of the following conditions: * AST ≥ 35 UI/L * ALT ≥ 35 UI/L * GGT ≥ 38 UI/L * ALP ≥ 116 UI/L * Presence of hepatic steatosis

  Baseline

Secondary Outcomes (2)

• Comparison of liver morpho-functional parameters with results obtained by fibroscan.

  Baseline

• Comparison of liver morpho-functional parameters with results obtained by fibroscan.

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: * Diagnosis of Turner syndrome made by karyotype analysis on peripheral blood. * Age 18 years or older * Written informed consent obtained
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be enrolled from the cohort of adult TS patients under longitudinal monitoring at the U.O.C. of Endocrinology and Diabetes Prevention and Care IRCCS Policlinico S. Orsola.

You may qualify if:

• Diagnosis of Turner syndrome made by karyotype analysis on peripheral blood.
• Age 18 years or older
• Written informed consent obtained

You may not qualify if:

• TS patients on therapy with drugs responsible for significant liver enzyme alterations (liver function alteration, LFA).

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Turner Syndrome

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Alessandra Gambineri, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Gambineri, MD

CONTACT

+390512144628; alessandra.gambineri@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 27, 2025
• Study Start: January 7, 2025
• Primary Completion: January 6, 2026
• Study Completion: January 7, 2026
• Last Updated: January 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)