De Novo Metabolic Syndrome in Liver Transplant Patients A... | NCT05808192

Studies
De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal

NCT05808192

Sponsor

University of Rome Tor Vergata

Status

Completed

Last Update Posted

Apr 11, 2023Actual

Enrollment

92Actual

Phase

Not provided

Conditions

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

Interventions

Immunosuppressive

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Feb 1, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Mar 29, 2023

First Submission Date that Met QC Criteria

Mar 29, 2023

First Posted Date

Apr 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2023

Last Update Posted Date

Apr 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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").

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tolerant		patients who withdraw IS drugs after LT	Drug: Immunosuppressive
non tolerant		patients who couldn't wean IS drugs	Drug: Immunosuppressive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunosuppressive	Drug	compare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend.	non tolerant tolerant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

49 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Roberta Angelico		Rome		00133	Italy

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007166	Immunosuppressive Agents

Ancestor Terms

ID	Term
D007155	Immunologic Factors
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided