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

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

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Genetic Predisposition to Disease; Multiple Organ Failure; Intensive Care Unit Syndrome
• Intervention / Treatment: Genetic: genetic analysis; Biological: blood and stools samples

• Study Type: Observational
• Enrollment (Actual): 994

Contacts and Locations

Study Locations

• France
  • Caen, France
    • CHU Côte de Nacre
  • Lille, France
    • Hôpital Roger Salengro, CHRU de Lille
  • Roubaix, France
    • CH Victor Provot
  • Rouen, France
    • CHU Charles Nicolle
  • Tourcoing, France
    • Ch Tourcoing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients admitted in ICU > 48h with at least one organ dysfunction

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in inflammatory markers		one year after inclusion
Changes in serum lipid profile	Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides	one year after inclusion
Changes in liver enzymes	Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST)	one year after inclusion
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Mercedes Jourdain, MD, PhD, University Hospital, Lille

Publications and helpful links

General Publications

• Ben Hamou A, Kipnis E, Elbaz A, Bignon A, Nseir S, Tamion F, Du Cheyron D, Jaillette E, Voisin B, Robriquet L, Vanbaelinghem C, Thellier D, Abi Rached H, Jannin A, Duhamel A, Behal H, Machuron F, Espiard S, Preiser JC, Preau S, Pattou F, Jourdain M. Association of transcription factor 7-like 2 gene (TCF7L2) polymorphisms with stress-related hyperglycaemia (SRH) in intensive care and resulting outcomes: The READIAB study. Diabetes Metab. 2020 Jun;46(3):243-247. doi: 10.1016/j.diabet.2019.05.001. Epub 2019 May 20.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: diabetes; biobank; hyperglycemia; Multiple Organ Failure
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Shock; Disease Susceptibility; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus; Hyperglycemia; Multiple Organ Failure; Genetic Predisposition to Disease; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Genetic Techniques; Genetic Services; Diagnostic Services; Genetic Testing; Blood Specimen Collection
• Other Study ID Numbers: 2009_58; 2010-A00997-32 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO