De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

Completed

• Conditions: Single Transplant; 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS
• Interventions: Drug: Immunosuppressive

• Registration Number: NCT05808192
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those taking immunosuppressive therapy ("non-tolerant").

Detailed Description

A retrospective single-center study was conducted aiming to define the incidence of de novo Metabolic Syndrome (MS) in patients who withdraw Immunosoppression (IS) drugs after Liver Transplant (Tolerant-group) compared to these who couldn't wean IS drugs(non-TOL-group).

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-05-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• single LT recipients with an attempt of IS withdrawal
• minimum 5 years follow-up

Exclusion Criteria

• Liver transplant combined with other organs
• Presence of metabolic syndrome and/or NASH and/or NAFLD as an indication for liver transplantation
• Loss of patient to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tolerant	Immunosuppressive	patients who withdraw IS drugs after LT
non tolerant	Immunosuppressive	patients who couldn't wean IS drugs

Primary Outcome Measures

Name	Time	Method
relation between MS development and IS in LT recipients	5 years	Evaluate the de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those who could not withdraw IS ("non-tolerant").

Secondary Outcome Measures

Name	Time	Method
IS withdrawal in LT recipients	5 years	Evaluate the clinical course of patients undergoing discontinuation of immunosuppressive therapy

Trial Locations

Locations (1)

Roberta Angelico; 🇮🇹 Rome, Italy