Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-01 @ 5:19 AM
Study NCT ID:
NCT03055169
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2016-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood, plasma, mononuclear cells, DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 994}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood samples collection', 'timeFrame': '5 years', 'description': 'the blood samples collection will created for next research Both on diabetes and / or insulin resistance as its determinisms, at the ICU patient'}, {'measure': 'Number of patients with genotype TCF7L2 by PCR', 'timeFrame': '5 years', 'description': 'the prevalence of TCF7L2, in the intensive care patient or not glycemic control, and compared to the values found in the general population.\n\nthe TCF7L2 genes will be evaluated by the Taqman method (7900HT Fast Real-Time PCR System-Applied BioSystem).'}], 'primaryOutcomes': [{'measure': 'value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of hyperglycemia', 'timeFrame': 'one year after inclusion', 'description': 'find a link between genetic polymorphism of TCF7L2 and the risk of developing hyperglycemia in intensive care patients with a least one organ dysfunction.\n\nthe hyperglycemia is defined fasting glucose\\> 1.26 g / l twice or need for treatment with insulin)'}], 'secondaryOutcomes': [{'measure': 'Changes in inflammatory markers', 'timeFrame': 'one year after inclusion'}, {'measure': 'Changes in serum lipid profile', 'timeFrame': 'one year after inclusion', 'description': 'Changes in cholesterol total, LDL cholesterol, HDL cholesterol and triglycerides'}, {'measure': 'Changes in liver enzymes', 'timeFrame': 'one year after inclusion', 'description': 'Changes in total alanine transaminase (ALT) total gamma-GT total aspartate transaminase (AST)'}, {'measure': 'Insulin Resistance (HOMA)', 'timeFrame': 'one year after inclusion', 'description': 'Calculated using the updated homeostasis model assessment (HOMA) calculator.Higher numbers indicate higher insulin resistance. There are no established cutoffs indicating impaired resistance.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyperglycemia', 'Multiple Organ Failure', 'biobank', 'diabetes'], 'conditions': ['Genetic Predisposition to Disease', 'Hyperglycemia', 'Intensive Care Unit Syndrome', 'Multiple Organ Failure']}, 'referencesModule': {'references': [{'pmid': '31121319', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted in ICU \\> 48h with at least one organ dysfunction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admission in ICU\\>48h\n* at least one organ dysfunction\n\nExclusion Criteria:\n\n* age\\< 18 years\n* pregnant women\n* admission less than 48h'}, 'identificationModule': {'nctId': 'NCT03055169', 'acronym': 'READIAB-G4', 'briefTitle': 'TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure', 'orgStudyIdInfo': {'id': '2009_58'}, 'secondaryIdInfos': [{'id': '2010-A00997-32', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'intensive care patients', 'description': 'patients with a least one organ dysfunction', 'interventionNames': ['Genetic: genetic analysis', 'Biological: blood and stools samples']}], 'interventions': [{'name': 'genetic analysis', 'type': 'GENETIC', 'armGroupLabels': ['intensive care patients']}, {'name': 'blood and stools samples', 'type': 'BIOLOGICAL', 'armGroupLabels': ['intensive care patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'CHU Cote de Nâcre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Roubaix', 'country': 'France', 'facility': 'CH Victor Provot', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Tourcoing', 'country': 'France', 'facility': 'CH Tourcoing', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}], 'overallOfficials': [{'name': 'Mercedes Jourdain, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}