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Completed

NCT Number: NCT03055169

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

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

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Key information

Conditions

Genetic Predisposition to Disease Diabetes Mellitus Disease Attributes Disease Susceptibility Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Intensive Care Unit Syndrome Metabolic Diseases Multiple Organ Failure Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Cote de Nâcre, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Genetic analysis

Genetic

blood and stools samples

Biological

Primary outcomes

  1. 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)

Secondary outcomes

  1. Changes in inflammatory markers

    Time frame: one year after inclusion

  2. Changes in serum lipid profile

    Time frame: one year after inclusion

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

  3. Changes in liver enzymes

    Time frame: one year after inclusion

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

  4. 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.

Other outcomes

  1. 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

  2. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: READIAB-G4

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Feb 16, 2017
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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