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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055169
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date July 13, 2016
First Posted Date February 16, 2017
Last Update Posted Date May 3, 2018
Actual Study Start Date April 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2017)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 13, 2017)
  • Changes in inflammatory markers [ Time Frame: one year after inclusion ]
  • Changes in serum lipid profile [ Time Frame: one year after inclusion ]
    Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides
  • Changes in liver enzymes [ Time Frame: one year after inclusion ]
    Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST)
  • Insulin Resistance (HOMA) [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 13, 2017)
  • Blood samples collection [ Time Frame: 5 years ]
    the blood samples collection will created for next research Both on diabetes and / or insulin resistance as its determinisms, at the ICU patient
  • Number of patients with genotype TCF7L2 by PCR [ Time Frame: 5 years ]
    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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure
Official Title TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood, plasma, mononuclear cells, DNA
Sampling Method Non-Probability Sample
Study Population patients admitted in ICU > 48h with at least one organ dysfunction
Condition
  • Genetic Predisposition to Disease
  • Hyperglycemia
  • Intensive Care Unit Syndrome
  • Multiple Organ Failure
Intervention
  • Genetic: genetic analysis
  • Biological: blood and stools samples
Study Groups/Cohorts intensive care patients
patients with a least one organ dysfunction
Interventions:
  • Genetic: genetic analysis
  • Biological: blood and stools samples
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 2, 2018)
994
Original Estimated Enrollment
 (submitted: February 13, 2017)
1000
Actual Study Completion Date August 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age< 18 years
  • pregnant women
  • admission less than 48h
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03055169
Other Study ID Numbers 2009_58
2010-A00997-32 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Mercedes Jourdain, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date May 2018