De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

NCT ID: NCT05808192

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-05-01

Brief Summary

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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

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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).

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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tolerant

patients who withdraw IS drugs after LT

Immunosuppressive

Intervention Type DRUG

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

Immunosuppressive

Intervention Type DRUG

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

Interventions

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Immunosuppressive

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

49 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Roberta Angelico

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Roberta Angelico

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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R.S.123.20

Identifier Type: -

Identifier Source: org_study_id

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