De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

March 29, 2023 updated by: Roberta Angelico, University of Rome Tor Vergata
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").

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00133
        • Roberta Angelico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

92 patients with liver transplantation who attempted to suspend/ achieve suspension of immunosuppressive therapy, in follow-up in Tor Vergata transplant center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
tolerant
patients who withdraw IS drugs after LT
Drug: Immunosuppressive
compare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend.
non tolerant
patients who couldn't wean IS drugs
Drug: Immunosuppressive
compare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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").
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IS withdrawal in LT recipients
Time Frame: 5 years
Evaluate the clinical course of patients undergoing discontinuation of immunosuppressive therapy
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.S.123.20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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