Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-19 @ 3:44 PM
Study NCT ID:
NCT01739868
Status:
UNKNOWN
Last Update Posted:
2015-04-16
First Post:
2012-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening and Understanding of the Pre-diabetes: DECODIAB
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'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2012-11-23', 'studyFirstSubmitQcDate': '2012-11-28', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify new biomarkers', 'timeFrame': '5 years', 'description': '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 the population of patients with pre-diabetes'}], 'secondaryOutcomes': [{'measure': 'To identify new therapeutic targets', 'timeFrame': '5 years', 'description': 'To identify new therapeutic targets for the prevention of the appearance of the diabetes in the population of patients with pre-diabetes'}, {'measure': 'To connect identified biomarkers with the degree of insulinoresistance', 'timeFrame': '5 years', 'description': 'To connect identified biomarkers with the degree of insulinoresistance (HOMA-R) and with β pancreatic function (IOG) in the population of patients with pre-diabetes.'}, {'measure': 'Number of patients with high Diabetes Risk Score and pre-diabetes', 'timeFrame': '5 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': '5 years', 'description': 'To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pre-diabetes', 'Type 2 diabetes', 'Biomarkers', 'Diabetes risk score'], 'conditions': ['Pre-diabetes']}, 'descriptionModule': {'briefSummary': '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 the population of patients with pre-diabetes.'}, '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 ≥ 12 or with impaired fasting glucose: blood glucose ≥ 1.10 g/l and \\< 1 .26 g/L\n* And with impaired fasting glucose : blood glucose ≥ 1.10 g/l and \\< 1 .26 g/L ; or blood glucose ≥ 1g/l and \\< 1,1 g/L WITH HbA1C ≥ 6,5%\n* Signed informed consent\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 AND HbA1C \\< 6,5%\n* Fasting glycemia \\< 1 g/l\n* Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV.\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\n* Alcohol abuse (\\> 30g/j)\n* Contra-indication in the realization of the local anesthetic\n* Subject unable to follow the study during the 5 years of follow-up\n* Subject exclusion period in a previous study'}, 'identificationModule': {'nctId': 'NCT01739868', 'acronym': 'DECODIAB', 'briefTitle': 'Screening and Understanding of the Pre-diabetes: DECODIAB', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Screening and Understanding of the Pre-diabetes: DECODIAB', 'orgStudyIdInfo': {'id': '09/9-A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biopsies of muscular and fat tissue', 'type': 'OTHER', 'description': '3 half days of metabolic exploration including blood sample, urinary taking, OGTT (oral glucose tolerance test), biopsies of muscular and fat tissue:\n\n* 1 visit the first year (inclusion visit)\n* 1 visit at the end of 5 years of follow-up or in the appearance of type 2 diabetes\n* 1 intermediary visit (in 3 years) or activated by the following conditions:\n\n * Escalation of the glycemia (increase of 0.1g / l of the glycemia and/or 0.3 % of the HbA1c)\n * Normalization of the glycemia (fasting blood glucose \\< 1 g/l)'}]}, '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': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}