De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

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").

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Key information

Conditions

Single Transplant 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

49 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Roberta Angelico

Rome, 00133, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunosuppressive

Drug

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

Primary outcomes

relation between MS development and IS in LT recipients

Time frame: 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 outcomes

IS withdrawal in LT recipients

Time frame: 5 years

Evaluate the clinical course of patients undergoing discontinuation of immunosuppressive therapy

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Apr 11, 2023
Registry last updated: Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed