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

Completed

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

• Registration Number: NCT03055169
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2016-07-13
• Primary Completion: 2016-08
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Study Completion: 2017-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 994

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intensive care patients	genetic analysis	patients with a least one organ dysfunction
intensive care patients	blood and stools samples	patients with a least one organ dysfunction

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes in inflammatory markers	one year after inclusion
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.
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)

Trial Locations

Locations (5)

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