Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-03-17 @ 11:42 PM
Study NCT ID:
NCT02201550
Status:
COMPLETED
Last Update Posted:
2014-07-28
First Post:
2014-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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 samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-24', 'studyFirstSubmitDate': '2014-07-24', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of specific immune cells in blood detected by flow cytometry', 'timeFrame': 'Before and 12 weeks after initiation of liraglutide treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on the immune system i.e on the regulation of immune cells important in diseases such as obesity and diabetes.\n\nThe hypotheses are:\n\n* Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in the blood\n* Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood\n* Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine profile in the blood'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 diabetes undertaking treatment with liraglutide', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* BMI \\> 27 kg/m2\n* Planed start of treatment with liraglutide\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Infection or active inflammatory disorder\n* Immunomodulating treatment (i.e nonsteroidal antiinflammatory drugs, glucocorticoids)\n* Smoking\n* Alcohol consumption \\> 14 beverages/week\n* Former bariatric surgery'}, 'identificationModule': {'nctId': 'NCT02201550', 'briefTitle': 'Study of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Regulation of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide (Victoza)', 'orgStudyIdInfo': {'id': 'H-2-2012-148-KLB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liraglutide', 'description': 'Patients with type 2 diabetes undertaking treatment with liraglutide'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Carsten Dirksen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}, {'name': 'Sten Madsbad, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zealand Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Carsten Dirksen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}