Genetic Predisposition to DiseaseREADIAB-G4NCT03055169
TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure
An observational study of Genetic Predisposition to Disease and Hyperglycemia, run by University Hospital, Lille at 5 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Genetic Predisposition to Disease, Hyperglycemia, Intensive Care Unit Syndrome
- What is being tested?
- genetic analysis and blood and stools samples
- How many people
- 994 participants
- Where
- 5 sitesFrance
- Study dates
- Apr 2012to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted in ICU > 48h with at least one organ dysfunction
Who may be able to join
- admission in ICU>48h
- at least one organ dysfunction
Who cannot join
- age< 18 years
- pregnant women
- admission less than 48h
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Cote de Nâcre
Caen
Hôpital Roger Salengro, CHRU de Lille
Lille
CH Victor Provot
Roubaix
CHU Charles Nicolle
Rouen
CH Tourcoing
Tourcoing
About this study
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
- Conditions
- Genetic Predisposition to Disease, Hyperglycemia, Intensive Care Unit Syndrome, Multiple Organ Failure
- Being tested
- genetic analysis, blood and stools samples
- Keywords
- hyperglycemia, Multiple Organ Failure, biobank, diabetes
- Medical subject headings
- Genetic Predisposition to Disease, Hyperglycemia, Multiple Organ Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic analysisGenetic
blood and stools samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| intensive care patients | patients with a least one organ dysfunction Receives: Genetic: genetic analysis; Biological: blood and stools samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one year after inclusion
Secondary outcomes (4)
Changes in inflammatory markers
Measured: one year after inclusion
Changes in serum lipid profile
Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides
Measured: one year after inclusion
Changes in liver enzymes
Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST)
Measured: 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.
Measured: one year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startApr 2012
- Primary completionAug 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genetic Predisposition to DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 994 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mercedes Jourdain, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055169
- Sponsor's protocol ID
- 2009_58
- Other IDs
- 2010-A00997-32
- Acronym
- READIAB-G4
- Status last verified
- May 2018
- First submitted
- 13 Jul 2016
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure
- ClinicalTrials.gov ID
- NCT03055169
- Acronym / sponsor ID
- READIAB-G4 / 2009_58
- Conditions
- Genetic Predisposition to Disease, Hyperglycemia, Intensive Care Unit Syndrome, Multiple Organ Failure
- Keywords
- hyperglycemia, Multiple Organ Failure, biobank, diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 994 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intensive care patients | – | Genetic: genetic analysis, Biological: blood and stools samplespatients with a least one organ dysfunction |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted in ICU > 48h with at least one organ dysfunction
Key inclusion criteria (2 listed)
- admission in ICU>48h
- at least one organ dysfunction
Key exclusion criteria (3 listed)
- age< 18 years
- pregnant women
- admission less than 48h
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic analysis | Genetic | intensive care patients |
| blood and stools samples | Biological | intensive care patients |
Primary outcome
value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of hyperglycemia
Time frame: 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)
4 secondary outcomes
Changes in inflammatory markers
Time frame: one year after inclusion
Changes in serum lipid profile
Time frame: one year after inclusion
Changes in liver enzymes
Time frame: one year after inclusion
Insulin Resistance (HOMA)
Time frame: one year after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 31121319Ben 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mercedes Jourdain, MD, PhD principal investigator
University Hospital, Lille
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Predisposition to Disease and Hyperglycemia, run by University Hospital, Lille at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of hyperglycemia (time frame: one year after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.