Skip to content

De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05808192
Enrollment
92
Registered
2023-04-11
Start date
2020-09-01
Completion date
2022-05-01
Last updated
2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS, Single Transplant

Keywords

Metabolic Syndrome, Liver transplantation, Immunosoppression, Tolerance

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).

Interventions

compare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend.

Sponsors

University of Rome Tor Vergata
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
49 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
relation between MS development and IS in LT recipients5 yearsEvaluate 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

MeasureTime frameDescription
IS withdrawal in LT recipients5 yearsEvaluate the clinical course of patients undergoing discontinuation of immunosuppressive therapy

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026