Cirrhosis, Effects of TRAnsplantation and Diabetes (CETRA)

This study is currently recruiting participants.
Verified March 2014 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor:
Information provided by (Responsible Party):
Emanuela Orsi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT02038517
First received: January 10, 2014
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition
Liver Cirrhosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Insulin Secretion and Sensitivity in Subjects With Liver Cirrhosis Undergoing Orthotopic Liver Transplantation (OLT): Pre- and Post-OLT Analysis

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • Relationship of insulin secretion and sensitivity with the development of abnormalities of glucose metabolism after OLT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Relationship of insulin secretion and sensitivity with morbidity and mortality after OLT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 morbidity and mortality after OLT.

  • Relationship of insulin secretion and sensitivity with the development of the metabolic syndrome after OLT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 the metabolic syndrome and its components (impaired glucose metabolism, central obesity, dyslipidemia and hypertension) after OLT.


Other Outcome Measures:
  • Prevalence and incidence of impaired glucose metabolism (IFG, IGT and diabetes) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Prevalence of unknown diabetes mellitus or IGT (normal levels of fasting glucose and HbA1c) pre-OLT and incidence of new-onset diabetes after transplantation (NODAT) or IFG/IGT

  • Prevalence and incidence of the metabolic syndrome and its components (central) obesity , dyslipidemia and hypertension [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Prevalence of the metabolic syndrome and its components (National Cholesterol Education Program - Adult Treatment Panel criteria, 2004 revision) pre-OLT and incidence of new-onset metabolic syndrome after transplantation

  • Morbidity and mortality after OLT [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Morbidity and mortality from OLT-related and unrelated causes, including rejection, infection, and cardiovascular disease


Biospecimen Retention:   Samples With DNA

Serum, plasma, urines and DNA


Estimated Enrollment: 200
Study Start Date: June 2013
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Secondary care outpatients clinic

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Known diabetes
  • Cystic fibrosis
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02038517

Contacts
Contact: Emanuela Orsi, MD +390255034590 e.orsi@policlinico.mi.it

Locations
Italy
Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico Recruiting
Milan, MI, Italy, 20122
Contact: Emanuela Orsi, MD    +390255034590    e.orsi@policlinico.mi.it   
Sub-Investigator: Elena Lunati, MD         
Sub-Investigator: Valeria Grancini, MD         
Sub-Investigator: Eva Palmieri, MD         
Sub-Investigator: Dario Zimbalatti, MD         
Sub-Investigator: Veronica Resi, MD         
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Principal Investigator: Emanuela Orsi, MD Endocrinology and Diabetes Unit, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy
  More Information

No publications provided

Responsible Party: Emanuela Orsi, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT02038517     History of Changes
Other Study ID Numbers: EDOMP-1301
Study First Received: January 10, 2014
Last Updated: March 24, 2014
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Insulin secretion
Insulin sensitivity
Orthotopic liver transplantation
Type 2 diabetes
Metabolic syndrome
Cardiovascular disease

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014