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

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT03055169

Collaborator

(none)

994

Enrollment

Locations

Actual Duration (Months)

198.8

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Genetic Predisposition to Disease Hyperglycemia Intensive Care Unit Syndrome Multiple Organ Failure	Genetic: genetic analysis Biological: blood and stools samples

Study Design

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 :

Apr 1, 2012

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

intensive care patients

patients with a least one organ dysfunction

Genetic: genetic analysis

Biological: blood and stools samples

Outcome Measures

Primary Outcome Measures

value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of hyperglycemia [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

Changes in inflammatory markers [one year after inclusion]
Changes in serum lipid profile [one year after inclusion]
Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides
Changes in liver enzymes [one year after inclusion]
Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST)
Insulin Resistance (HOMA) [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

Blood samples collection [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	CHU Cote de Nâcre	Caen	France
2	Hôpital Roger Salengro, CHRU de Lille	Lille	France
3	CH Victor Provot	Roubaix	France
4	CHU Charles Nicolle	Rouen	France
5	CH Tourcoing	Tourcoing	France