Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-25 @ 10:30 PM
Study NCT ID:
NCT01218061
Status:
UNKNOWN
Last Update Posted:
2017-06-16
First Post:
2010-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 366}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-14', 'studyFirstSubmitDate': '2010-10-07', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population', 'timeFrame': '10 years', 'description': 'The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population'}], 'secondaryOutcomes': [{'measure': 'Number of patients with pre-diabetes', 'timeFrame': '10 years', 'description': 'To evaluate the prevalence of pre-diabetes in the region of Nantes'}, {'measure': 'HbA1c measurement', 'timeFrame': '10 years', 'description': 'To evaluate the role of HbA1C in screening for pre-diabetes and T2D'}, {'measure': 'Number of patients with high Diabetes Risk Score and pre-diabetes', 'timeFrame': '10 years', 'description': 'To evaluate the interest of the Diabetes Risk Score in identifying subjects with pre-diabetes in the French population'}, {'measure': 'Number of patients with others cardiovascular risk factors', 'timeFrame': '10 years', 'description': 'To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease'}, {'measure': 'Relation between "working hours and conditions" and metabolic disease', 'timeFrame': '10 years', 'description': 'To evaluate the impact of working hours and conditions on the prevalence of metabolic diseases (pre-diabetes, dyslipidemia…)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pre-diabetes', 'Type 2 diabetes', 'Biomarkers', 'Cohort', 'Diabetes Risk Score'], 'conditions': ['Pre-diabetes']}, 'referencesModule': {'references': [{'pmid': '40192447', 'type': 'DERIVED', 'citation': 'Rodrigues Oliveira A, Chevalier C, Wargny M, Pakulska V, Caradeuc C, Cloteau C, Letertre MPM, Giraud N, Bertho G, Bigot-Corbel E, Carpentier M, Nouadje G, Coute Y, Le May C, Cariou B, Hadjadj S, Croyal M. Methylglyoxal-Induced Glycation of Plasma Albumin: From Biomarker Discovery to Clinical Use for Prediction of New-Onset Diabetes in Individuals with Prediabetes. Clin Chem. 2025 Apr 7:hvaf035. doi: 10.1093/clinchem/hvaf035. Online ahead of print.'}, {'pmid': '35130909', 'type': 'DERIVED', 'citation': 'Croyal M, Wargny M, Chemello K, Chevalier C, Blanchard V, Bigot-Corbel E, Lambert G, Le May C, Hadjadj S, Cariou B. Plasma apolipoprotein concentrations and incident diabetes in subjects with prediabetes. Cardiovasc Diabetol. 2022 Feb 7;21(1):21. doi: 10.1186/s12933-022-01452-5.'}, {'pmid': '31785259', 'type': 'DERIVED', 'citation': 'Chavez-Talavera O, Wargny M, Pichelin M, Descat A, Vallez E, Kouach M, Bigot-Corbel E, Joliveau M, Goossens JF, Le May C, Hadjadj S, Hanf R, Tailleux A, Staels B, Cariou B. Bile acids associate with glucose metabolism, but do not predict conversion from impaired fasting glucose to diabetes. Metabolism. 2020 Feb;103:154042. doi: 10.1016/j.metabol.2019.154042. Epub 2019 Nov 27.'}, {'pmid': '31465427', 'type': 'DERIVED', 'citation': 'Wargny M, Smati S, Pichelin M, Bigot-Corbel E, Authier C, Dierry V, Zair Y, Jacquin V, Hadjadj S, Boursier J, Cariou B. Fatty liver index is a strong predictor of changes in glycemic status in people with prediabetes: The IT-DIAB study. PLoS One. 2019 Aug 29;14(8):e0221524. doi: 10.1371/journal.pone.0221524. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients (≥18 years)\n* Subjects with diabetes risk score ≥ 15\n* Subjects with impaired fasting glucose: blood glucose ≥ 1.10 g/l and \\< 1 .26 g/L\n* Subjects affiliated with an appropriate social security system\n\nExclusion Criteria:\n\n* Fasting glycemia ≥ 1.26 g/l\n* Fasting glycemia ≤ 1.10 g/l\n* Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV, GLP-1 R agonists.\n* Subjects previously treated with insulin, except gestational diabetes\n* Severe coagulation disorders\n* Thrombocytopenia \\< 100 000/mm 3\n* Severe psychiatric disorders\n* Severe renal insufficiency (creatinine clearance \\< 30 ml/min)\n* Severe hepatic insufficiency (TP \\< 50%)\n* Alcohol abuse (\\> 30g/j)\n* Patient's opposition\n* Subject unable to follow the study during the 5 years of follow-up\n* Subject exclusion period in a previous study"}, 'identificationModule': {'nctId': 'NCT01218061', 'acronym': 'IT-DIAB', 'briefTitle': 'Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 10 Years', 'orgStudyIdInfo': {'id': 'PROG/09/11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pre-diabetes screening', 'type': 'OTHER', 'description': 'The timing of the study is :- Screening of high metabolic risk patients based on a clinical score : Finnish Diabetes Risk Score ≥ 15- if Diabetes Risk Score ≥ 15 or if history of blood glucose between 1.10 and 1.26 g/l (impaired fasting glucose): measuring fasting glycaemia + HbA1C + lipids profile + creatinemia + liver enzymes- if fasting blood glucose between 1.10 and 1.26 g/l (=V0):\\* OGTT (oral glucose tolerance test) to identify subjects with impaired glucose tolerance (optional)\\* establishment of a serum bank to identify biomarkers (serum, genomic, proteomic) - to plan for 10 years annual follow-up (V1 to V10) with blood sample (fasting glycemia + HbA1C + lipids profile + creatinemia + liver enzymes + serum bank (not after V5)) Making a total of 11 visits (V0-V10) with 6 blood samples.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Bertrand Cariou, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}