TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure (READIAB-G4)

May 2, 2018 updated by: University Hospital, Lille
This study evaluates the link between genetic polymorphisms as r7903146, rs12255372 of TCF7L2 gene and the risk of developing hyperglycemia during Intensive care unit stay

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

994

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • CHU côte de Nacre
      • Lille, France
        • Hôpital Roger Salengro, CHRU de Lille
      • Roubaix, France
        • CH Victor Provot
      • Rouen, France
        • Chu Charles Nicolle
      • Tourcoing, France
        • Ch Tourcoing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients admitted in ICU > 48h with at least one organ dysfunction

Description

Inclusion Criteria:

  • admission in ICU>48h
  • at least one organ dysfunction

Exclusion Criteria:

  • age< 18 years
  • pregnant women
  • admission less than 48h

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
intensive care patients
patients with a least one organ dysfunction
Genetic: genetic analysis
Biological: blood and stools samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of hyperglycemia
Time Frame: one year after inclusion

find a link between genetic polymorphism of TCF7L2 and the risk of developing hyperglycemia in intensive care patients with a least one organ dysfunction.

the hyperglycemia is defined fasting glucose> 1.26 g / l twice or need for treatment with insulin)
one year after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in inflammatory markers
Time Frame: one year after inclusion
one year after inclusion
Changes in serum lipid profile
Time Frame: one year after inclusion
Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides
one year after inclusion
Changes in liver enzymes
Time Frame: one year after inclusion
Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST)
one year after inclusion
Insulin Resistance (HOMA)
Time Frame: one year after inclusion
Calculated using the updated homeostasis model assessment (HOMA) calculator.Higher numbers indicate higher insulin resistance. There are no established cutoffs indicating impaired resistance.
one year after inclusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood samples collection
Time Frame: 5 years
the blood samples collection will created for next research Both on diabetes and / or insulin resistance as its determinisms, at the ICU patient
5 years
Number of patients with genotype TCF7L2 by PCR
Time Frame: 5 years

the prevalence of TCF7L2, in the intensive care patient or not glycemic control, and compared to the values found in the general population.

the TCF7L2 genes will be evaluated by the Taqman method (7900HT Fast Real-Time PCR System-Applied BioSystem).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Mercedes Jourdain, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009_58
  • 2010-A00997-32 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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