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

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ClinicalTrials.gov Identifier: NCT03055169
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment
Genetic Predisposition to Disease Hyperglycemia Intensive Care Unit Syndrome Multiple Organ Failure Genetic: genetic analysis Biological: blood and stools samples

Study Design
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Study Type : Observational
Actual Enrollment : 994 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure
Actual Study Start Date : April 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

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


Outcome Measures
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Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. Changes in inflammatory markers [ Time Frame: one year after inclusion ]
  2. Changes in serum lipid profile [ Time Frame: one year after inclusion ]
    Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides

  3. Changes in liver enzymes [ Time Frame: one year after inclusion ]
    Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST)

  4. 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.


Other Outcome Measures:
  1. 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

  2. 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).



Biospecimen Retention:   Samples With DNA
blood, plasma, mononuclear cells, DNA

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients admitted in ICU > 48h with at least one organ dysfunction
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age< 18 years
  • pregnant women
  • admission less than 48h
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055169


Locations
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France
CHU Cote de Nâcre
Caen, France
Hôpital Roger Salengro, CHRU de Lille
Lille, France
CH Victor Provot
Roubaix, France
CHU Charles Nicolle
Rouen, France
CH Tourcoing
Tourcoing, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Mercedes Jourdain, MD, PhD University Hospital, Lille
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03055169    
Other Study ID Numbers: 2009_58
2010-A00997-32 ( Other Identifier: ID-RCB number, ANSM )
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
hyperglycemia
Multiple Organ Failure
biobank
diabetes
Additional relevant MeSH terms:
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Hyperglycemia
Disease Susceptibility
Genetic Predisposition to Disease
Multiple Organ Failure
Glucose Metabolism Disorders
 Metabolic Diseases
Disease Attributes
Pathologic Processes
Shock