NCT05808192

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").

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
Last Updated

April 11, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

March 29, 2023

Last Update Submit

March 29, 2023

Conditions

Single Transplant5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS

Keywords

Metabolic Syndrome, Liver transplantation, Immunosoppression, Tolerance

Outcome Measures

Primary Outcomes (1)

  • relation between MS development and IS in LT recipients

    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 Outcomes (1)

  • IS withdrawal in LT recipients

    5 years

Study Arms (2)

tolerant

patients who withdraw IS drugs after LT

Drug: Immunosuppressive

non tolerant

patients who couldn't wean IS drugs

Drug: Immunosuppressive

Interventions

ImmunosuppressiveDRUG

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

non toleranttolerant

Eligibility Criteria

Age49 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • single LT recipients with an attempt of IS withdrawal
  • minimum 5 years follow-up

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roberta Angelico

Rome, 00133, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Immunosuppressive Agents

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Immunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 11, 2023

Study Start

September 1, 2020

Primary Completion

February 1, 2022

Study Completion

May 1, 2022

Last Updated

April 11, 2023

Record last verified: 2023-03

Locations

IT(1)