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
|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 Type :||Observational|
|Actual Enrollment :||994 participants|
|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|
intensive care patients
patients with a least one organ dysfunction
Genetic: genetic analysis
Biological: blood and stools samples
- 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)
- Changes in inflammatory markers [ Time Frame: 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
- Changes in liver enzymes [ Time Frame: one year after inclusion ]Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST)
- 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.
- 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
- 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
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
|CHU Cote de Nâcre|
|Hôpital Roger Salengro, CHRU de Lille|
|CH Victor Provot|
|CHU Charles Nicolle|
|Principal Investigator:||Mercedes Jourdain, MD, PhD||University Hospital, Lille|