NCT03055169

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
994

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2018

Enrollment Period

4.3 years

First QC Date

July 13, 2016

Last Update Submit

May 11, 2026

Conditions

HyperglycemiaMultiple Organ FailureGenetic Predisposition to DiseaseIntensive Care Unit Syndrome

Keywords

hyperglycemiaMultiple Organ Failurebiobankdiabetes

Outcome Measures

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)

    one year after inclusion

Secondary Outcomes (4)

  • Changes in inflammatory markers

    one year after inclusion

  • Changes in serum lipid profile

    one year after inclusion

  • Changes in liver enzymes

    one year after inclusion

  • Insulin Resistance (HOMA)

    one year after inclusion

Other Outcomes (2)

  • Blood samples collection

    5 years

  • Number of patients with genotype TCF7L2 by PCR

    5 years

Study Arms (1)

intensive care patients

patients with a least one organ dysfunction

Genetic: genetic analysisBiological: blood and stools samples

Interventions

genetic analysisGENETIC
intensive care patients
blood and stools samplesBIOLOGICAL
intensive care patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Cote de Nâcre

Caen, France

Location

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

CH Victor Provot

Roubaix, France

Location

CHU Charles Nicolle

Rouen, France

Location

CH Tourcoing

Tourcoing, France

Location

Related Publications (1)

  • 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.

    PMID: 31121319RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood, plasma, mononuclear cells, DNA

MeSH Terms

Conditions

Genetic Predisposition to DiseaseHyperglycemiaMultiple Organ FailureDiabetes Mellitus

Interventions

Genetic TestingBlood Specimen Collection

Condition Hierarchy (Ancestors)

Disease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesShockEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health ServicesSpecimen HandlingPuncturesSurgical Procedures, Operative

Study Officials

  • Mercedes Jourdain, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

February 16, 2017

Study Start

April 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

May 14, 2026

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)