Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-04 @ 7:41 PM
Study NCT ID:
NCT02542735
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2015-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Type 2 Diabetes in the di@Bet.es Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-09-25', 'releaseDate': '2020-09-07'}, {'resetDate': '2024-09-12', 'releaseDate': '2024-04-16'}], 'estimatedResultsFirstSubmitDate': '2020-09-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood Serum and DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2408}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-29', 'studyFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type 2 diabetes incidence', 'timeFrame': '6 years on average', 'description': 'Presence of type 2 diabetes mellitus diagnosed by OGTT after 6 years of follow up in a Spanish population.'}, {'measure': 'Metabolic syndrome incidence', 'timeFrame': '6 years on average', 'description': 'Presence of metabolic syndrome (according ATPIII criteria) after 6 years of follow up in a Spanish population.'}], 'secondaryOutcomes': [{'measure': 'Risk of diabetes according to each of the measured SNP', 'timeFrame': '6 years on average', 'description': 'To show that the presence of particular alleles of genes encoding fatty acid transporters and their regulatory proteins (VEGF-B) are associated with the risk of developing type 2 diabetes after six years of follow up.'}, {'measure': 'Risk of metabolic syndrome according to each of the measured SNP', 'timeFrame': '6 years on average', 'description': 'To show that the presence of particular alleles of genes encoding fatty acid transporters and their regulatory proteins (VEGF-B) are associated with the risk of developing metabolic syndrome after six years of follow up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '21987347', 'type': 'BACKGROUND', 'citation': 'Soriguer F, Goday A, Bosch-Comas A, Bordiu E, Calle-Pascual A, Carmena R, Casamitjana R, Castano L, Castell C, Catala M, Delgado E, Franch J, Gaztambide S, Girbes J, Gomis R, Gutierrez G, Lopez-Alba A, Martinez-Larrad MT, Menendez E, Mora-Peces I, Ortega E, Pascual-Manich G, Rojo-Martinez G, Serrano-Rios M, Valdes S, Vazquez JA, Vendrell J. Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the Di@bet.es Study. Diabetologia. 2012 Jan;55(1):88-93. doi: 10.1007/s00125-011-2336-9. Epub 2011 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'Our aim was to determine the incidence of type 2 diabetes mellitus in a nation-wide population based cohort from Spain (di@bet.es study). The target was the Spanish population. The sample consisted of 5072 people older than 18 years, in 100 clusters (health centres randomly selected from all over Spain). The following variables were recorded: Socio-demographic and clinical data, survey on habits (physical activity and frequency of selected food consumption) and a physical examination was made (weight, height, waist, hip, blood pressure). A fasting blood draw and an oral glucose tolerance test were performed. Determinations of serum glucose were made. In the follow-up the same variables were collected and HbA1c was determined. A total of 2408 subjects participated in the follow-up (7.5±0.6 years, 39.7% men). In total, 154 people developed diabetes (6.4% cumulative incidence in the 7.5 years of follow-up). The incidence of total diabetes adjusted for the structure of age and sex of the Spanish population was 11.6 cases/1000 person-years (IC95%=11.1-12.1). The incidence of known diabetes was 3.7 cases/1000 person-years (IC95%=2.8-4.6) and the incidence of unknown diabetes was 7.9 cases/1000 person-years (IC95%=5.3-8.1). The main risk factors for developing diabetes were the presence of prediabetes in cross-sectional study, age, male sex, obesity, central obesity, increase in weight, and family history of diabetes. This work provides data about population-based incidence rates of diabetes and associated risk factors in a nation-wide cohort of Spanish population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study is based on the di@bet.es study, a cross-sectional study undertaken from 2007-2010 from a random cluster sampling in the Spanish population over 18 years of age (Soriguer et al. Diabetologia 2012;55(1):88-93).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General Population\n\nExclusion Criteria:\n\n* diabetes in cross-sectional study\n* serious illness that prevents participation\n* pregnancy\n* surgery within the previous month\n* any other disabling situation that prevents participation'}, 'identificationModule': {'nctId': 'NCT02542735', 'briefTitle': 'Incidence of Type 2 Diabetes in the di@Bet.es Study', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud'}, 'officialTitle': 'Incidence of Type 2 Diabetes in the di@Bet.es Study: Role of Fatty Acid Transport System Regulated by VEGFB in the Development of Metabolic Diseases.', 'orgStudyIdInfo': {'id': 'PI14/00710'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spanish di@bet.es cohort', 'description': 'Representative of Spanish population'}]}, 'contactsLocationsModule': {'locations': [{'zip': '29009', 'city': 'Málaga', 'state': 'Malaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}, {'name': 'Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Gemma Rojo', 'investigatorAffiliation': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-09-07', 'type': 'RELEASE'}, {'date': '2020-09-25', 'type': 'RESET'}, {'date': '2024-04-16', 'type': 'RELEASE'}, {'date': '2024-09-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Gemma Rojo, Senior Researcher, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud'}}}}