De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

• Sponsor: University of Rome Tor Vergata (Other)
• Overall Status: Completed
• CT.gov ID: NCT05808192
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Actual Duration (Months): 19.9
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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").

Condition or Disease	Intervention/Treatment	Phase
Single Transplant; 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS	Drug: Immunosuppressive

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 Design

• Study Type: Observational
• Actual Enrollment: 92 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Feb 1, 2022
• Actual Study Completion Date: May 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. IS withdrawal in LT recipients [5 years]

   Evaluate the clinical course of patients undergoing discontinuation of immunosuppressive therapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 49 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roberta Angelico	Rome		Italy	00133

Sponsors and Collaborators

• University of Rome Tor Vergata

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roberta Angelico, Professor, University of Rome Tor Vergata
• ClinicalTrials.gov Identifier: NCT05808192
• Other Study ID Numbers: R.S.123.20
• First Posted: Apr 11, 2023
• Last Update Posted: Apr 11, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Roberta Angelico, Professor, University of Rome Tor Vergata: Metabolic Syndrome, Liver transplantation, Immunosoppression, Tolerance
• Additional relevant MeSH terms: Metabolic Syndrome; Immunosuppressive Agents

Study Results

No Results Posted as of Apr 11, 2023