Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT01313156
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2011-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LUPS-Lipids and Glucose Under Prospective Surveillance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D017566', 'term': 'Microvascular Angina'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'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'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1962}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2011-03-10', 'studyFirstSubmitQcDate': '2011-03-10', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic Syndrome, Type 2 Diabetes', 'timeFrame': '10 years', 'description': 'assessing risk factors, e.g. HDL, BMI, Blood Pressure, FPG'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome, Syndrome X, MetS,', 'Type 2 Diabetes'], 'conditions': ['Metabolic Syndrome', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '30477037', 'type': 'DERIVED', 'citation': 'Muller-Wieland D, Altenburg C, Becher H, Burchard J, Frisch A, Gebhard J, Haas J, Harth V, Heeren J, Hengelbrock J, von Karais M, Knebel B, Kotzka J, Lowe B, Marx N, Pinnschmidt H, Preisser A, Rose M, Sawitzky-Rose B, Scheja L, Terschuren C, Toller M, Vettorazzi E, Wegscheider K. Development of the Metabolic Syndrome: Study Design and Baseline Data of the Lufthansa Prevention Study (LUPS), A Prospective Observational Cohort Survey. Exp Clin Endocrinol Diabetes. 2020 Dec;128(12):777-787. doi: 10.1055/a-0767-6361. Epub 2018 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, non-randomized cohort study to analyse genetic variations, dietary patterns, perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic syndrome and type 2 diabetes', 'detailedDescription': 'The LUPS-study is a collaboration between Asklepios Clinics Hamburg GmbH and University Clinic Hamburg Eppendorf, Germany. This study is assessing a multitude of serum biomarkers, anthropometrics, dietary habits, physical activity, perceived stress along with genetic information from "healthy workers" (25-60years) to better understand phenotype-genotype associations leading to MetS and type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'so-called "Healthy-Workers", aged 25-60years, of Lufthansa-Technik, Hamburg, Germany, who voluntarily aggreed to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25-60 years men and women willing to give consent\n\nExclusion Criteria:\n\n* diabetes (type 1 or 2)'}, 'identificationModule': {'nctId': 'NCT01313156', 'acronym': 'LUPS', 'briefTitle': 'LUPS-Lipids and Glucose Under Prospective Surveillance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asklepios proresearch'}, 'officialTitle': 'Lipids and Glucose Under Prospective Surveillance', 'orgStudyIdInfo': {'id': 'AKS#1833'}}, 'contactsLocationsModule': {'locations': [{'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik St.Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Dirk Mueller-Wieland, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asklepios Klinik St.Georg, Hamburg, Germany'}, {'name': 'Karl Wegscheider, Prof., PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asklepios proresearch', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'City of Hamburg', 'class': 'OTHER_GOV'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}