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CompletedNCT03055169READIAB-G4Updated May 14, 2026

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

An observational study in Genetic Predisposition to Disease, Hyperglycemia and Intensive Care Unit Syndrome, sponsored by University Hospital, Lille. Completed at 5 sites in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
994
Ages
18 Years to 100 Years
Sex
All
01

Study 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

02

Conditions studied

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

Keywords

  • hyperglycemia
  • Multiple Organ Failure
  • biobank
  • diabetes
03

In context

Genetic Predisposition to Disease

241 studies on the registry are indexed under Genetic Predisposition to Disease; 95 are open to participants now.

This study's enrollment of 994 is above the median of 500 across 154 observational studies indexed under Genetic Predisposition to Disease.

Browse Genetic Predisposition to Disease studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • age\< 18 years
  • pregnant women
  • admission less than 48h
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
994 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • intensive care patients

    patients with a least one organ dysfunction

    Genetic: genetic analysis · Biological: blood and stools samples

Interventions

  • Geneticgenetic analysis
  • Biologicalblood and stools samples
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: one year after inclusion

Secondary outcomes

  1. Changes in inflammatory markers

    Time frame: one year after inclusion

  2. Changes in serum lipid profile

    Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides

    Time frame: one year after inclusion

  3. Changes in liver enzymes

    Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST)

    Time frame: one year after inclusion

  4. 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.

    Time frame: one year after inclusion

Other outcomes

  1. 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

    Time frame: 5 years

  2. 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).

    Time frame: 5 years

07

Study locations

5 sites
  • 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
08

References and documents

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. PubMed 31121319 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03055169
Responsible party
Sponsor
First posted
Feb 16, 2017
Start date
Apr 2012
Primary completion
Aug 2016
Completion
Aug 2017
Last update
May 14, 2026

Study contacts

Mercedes Jourdain, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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