TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure

Hyperglycemia Clinical Trial

— READIAB-G4  

Official title:

TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055169
• Other study ID #: 2009_58
• Secondary ID: 2010-A00997-32
• Status: Completed
• Start date: April 2012
• Est. completion date: August 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 994
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• admission in ICU>48h

• at least one organ dysfunction

Exclusion Criteria:

• age< 18 years

• pregnant women

• admission less than 48h

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition to Disease
• Hyperglycemia
• Intensive Care Unit Syndrome
• Multiple Organ Failure

Intervention

Genetic:
• genetic analysis

Biological:
• blood and stools samples

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood samples collection	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
Other	Number of patients with genotype TCF7L2 by PCR	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
Primary	value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of hyperglycemia	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	Changes in inflammatory markers		one year after inclusion
Secondary	Changes in serum lipid profile	Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides	one year after inclusion
Secondary	Changes in liver enzymes	Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST)	one year after inclusion
Secondary	Insulin Resistance (HOMA)	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