NCT02038517

Brief Summary

This observational study is aimed at assessing insulin secretion and sensitivity by the use of a mathematical modeling from oral glucose tolerance test in subjects with liver cirrhosis undergoing orthotopic liver transplantation (OLT), before and at various time points after OLT.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress98%
Jun 2013Dec 2026

Study Start

First participant enrolled

June 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

January 10, 2014

Last Update Submit

February 29, 2016

Conditions

Liver Cirrhosis

Keywords

Insulin secretionInsulin sensitivityOrthotopic liver transplantationType 2 diabetesMetabolic syndromeCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Relationship of insulin secretion and sensitivity with the development of abnormalities of glucose metabolism after OLT

    Relation between baseline values and changes with transplantation of measures of insulin secretion and sensitivity, as derived from of the analysis of OGTT by the use of a mathematical model (i.e. proportional and derivative control for insulin secretion and oral glucose insulin sensitivity - OGIS - for insulin sensitivity ) and the development of abnormalities of glucose metabolism after OLT.

    10 years

Secondary Outcomes (2)

  • Relationship of insulin secretion and sensitivity with morbidity and mortality after OLT

    10 years

  • Relationship of insulin secretion and sensitivity with the development of the metabolic syndrome after OLT

    10 years

Other Outcomes (3)

  • Prevalence and incidence of impaired glucose metabolism (IFG, IGT and diabetes)

    10 years

  • Prevalence and incidence of the metabolic syndrome and its components (central) obesity , dyslipidemia and hypertension

    10 years

  • Morbidity and mortality after OLT

    10 years

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Secondary care outpatients clinic

You may qualify if:

  • Subjects with end-stage liver cirrhosis in waiting list for orthotopic liver transplantation at the Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy

You may not qualify if:

  • Known diabetes
  • Cystic fibrosis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

RECRUITING

Related Publications (1)

  • Grancini V, Trombetta M, Lunati ME, Boselli ML, Gatti S, Donato MF, Palmieri E, Resi V, Pugliese G, Bonadonna RC, Orsi E. Central role of the beta-cell in driving regression of diabetes after liver transplantation in cirrhotic patients. J Hepatol. 2019 May;70(5):954-962. doi: 10.1016/j.jhep.2019.01.015. Epub 2019 Jan 21.

    PMID: 30677460DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, urines and DNA

MeSH Terms

Conditions

Liver CirrhosisInsulin ResistanceDiabetes Mellitus, Type 2Metabolic SyndromeCardiovascular Diseases

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Emanuela Orsi, MD

    Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuela Orsi, MD

CONTACT

+390255034590e.orsi@policlinico.mi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 16, 2014

Study Start

June 1, 2013

Primary Completion

December 1, 2016

Study Completion (Estimated)

December 1, 2026

Last Updated

March 1, 2016

Record last verified: 2016-02

Locations

IT(1)