Primary Biliary CholangitisLiver FibrosisCirrhosis, LiverBlood Sugar; High
Study summary
Primary Biliary Cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by the progressive destruction of small intrahepatic bile ducts, leading to chronic cholestasis, hepatic fibrosis, and, in advanced stages, cirrhosis. Recent advances in the understanding of PBC pathophysiology have highlighted the central role of immune, inflammatory, and metabolic alterations in disease onset and progression.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years
* Confirmed diagnosis of PBC (biochemical criteria, antibody positivity and/or histological examination)
* The patient is a candidate for first- or second-line PPAR agonist therapy, as clinical practice, for the treatment of PBC
* The patient requires comprehensive metabolic monitoring, as per clinical practice
* Signed the informed consent form
Exclusion Criteria:
* Patients with a prior diagnosis of diabetes mellitus currently on insulin therapy
* Patients on treatment known to significantly affect glycemic values (e.g., GLP-1 receptor agonists, SGLT2 inhibitors, systemic corticosteroids)
* Patients with a life expectancy or estimated time to liver transplantation of less than 6 months
Primary outcome measure(s)
Change from baseline to 3 months in glycated hemoglobin (HbA1c) levels (%) — 3-16 months Assessment of change in glycated hemoglobin (HbA1c) levels from baseline to 3 months in adult patients with Primary Biliary Cholangitis (PBC) treated with PPAR agonists in routine clinical practice.
Change from baseline to 3 months in fasting plasma glucose levels (mg/dL) — 3-16 months Assessment of change in fasting plasma glucose levels from baseline to 3 months in adult patients with Primary Biliary Cholangitis (PBC) treated with PPAR agonists in routine clinical practice.
Change from baseline to 3 months in continuous glucose monitoring-derived time in range (%) — 3-16 months Assessment of change in percentage of time in glucose range (70-180 mg/dL) derived from continuous glucose monitoring between baseline and 3 months in adult patients with Primary Biliary Cholangitis (PBC) treated with PPAR agonists in routine clinical practice.
Trial sites (1)
Facility
City
Region
Status
Fondazione Policlinico Universitario A. Gemelli IRCCS,UOC Medicina Interna e Gastroenterologia,Largo A. Gemelli
Roma
Italy
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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