Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT00781495
Status:
UNKNOWN
Last Update Posted:
2011-07-12
First Post:
2008-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-03-06', 'releaseDate': '2013-01-31'}], 'estimatedResultsFirstSubmitDate': '2013-01-31'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-11', 'studyFirstSubmitDate': '2008-10-28', 'studyFirstSubmitQcDate': '2008-10-28', 'lastUpdatePostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To detect an association between insulin-induced weight gain and physical activity levels', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To assess the relationship between insulin-induced weight gain and cardiovascular risk profile', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin'], 'conditions': ['Type 2 Diabetes Mellitus', 'Weight Gain']}, 'referencesModule': {'references': [{'pmid': '24065152', 'type': 'DERIVED', 'citation': 'Jansen HJ, Stienstra R, van Diepen JA, Hijmans A, van der Laak JA, Vervoort GM, Tack CJ. Start of insulin therapy in patients with type 2 diabetes mellitus promotes the influx of macrophages into subcutaneous adipose tissue. Diabetologia. 2013 Dec;56(12):2573-81. doi: 10.1007/s00125-013-3018-6. Epub 2013 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find determinants of insulin-induced weight gain in type 2 diabetes mellitus\n\nPrimary objective: To find an association between weight gain after start of insulin therapy and physical activity levels.', 'detailedDescription': 'Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes mellitus (T2DM), but often at the expense of weight gain. Insulin-induced weight gain is obviously undesirable in an already overweight population and may negatively affect blood pressure, lipid levels, inflammatory and fibrinolytic parameters, adipocytokines and also deter further optimization of insulin therapy. It is unknown what determinants predict insulin-induced weight gain in type 2 diabetes mellitus.\n\nThe aim of this study therefore, is to assess determinants of insulin-induced weight gain in type 2 diabetes mellitus. In a retrospective and cross-sectional study (Jansen HJ et al., submitted) two extreme subgroups were identified (subjects with a weight gain above 80th percentile) and subgroup non-weight gainers (subjects with a weight gain below the 20th percentile). It was found that the gainers had less energy expenditure after initiation of insulin therapy than non-weight gainers. Therefore, the primary aim of this study is to detect an association between energy expenditure and weight gain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 diabetes mellitus, selected from the out-patient clinic of the Radboud University Nijmegen Medical Centre and four other non-academic hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with type 2 diabetes mellitus\n* age 18-85 years\n* Hba1c at baseline \\< 12.0%\n* written informed consent\n\nExclusion Criteria:\n\n* Clinical evidence of psychiatric, renal, cardiovascular or liver or other diseases which may influence study results regarding glucose and weight\n* Patients with hormonal disorders which may influence weight (i.e. thyroid diseases), even if properly treated with stable hormonal levels\n* Excessive alcohol consumption (\\>20 g/day), and drug abuse\n* Use of thiazolidinedione derivatives (TZDs)\n* Pregnancy or intention to become pregnant during the study'}, 'identificationModule': {'nctId': 'NCT00781495', 'briefTitle': 'Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Determinants of Insulin-induced Weight Gain in Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'T2DM_insulin_weight gain'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'type 2 diabetes mellitus', 'interventionNames': ['Device: Sensewear Bodymedia armband']}], 'interventions': [{'name': 'Sensewear Bodymedia armband', 'type': 'DEVICE', 'otherNames': ['Sensewear Bodymedia system'], 'description': 'To assess physical activity levels patients will wear Sensewear bodymedia armband', 'armGroupLabels': ['type 2 diabetes mellitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Henry Jansen, M', 'role': 'CONTACT'}, {'name': 'Henry Jansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3400 NL', 'city': "'s-Hertogenbosch", 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Paetrick Netten, MD, PhD', 'role': 'CONTACT'}, {'name': 'Paetrick Netten, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jeroen Bosch Hospital', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': "'s-Hertogenbosch", 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Linda Kemink, MD, PhD', 'role': 'CONTACT'}, {'name': 'Linda Kemink, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jeroen Bosch Hospital', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}], 'centralContacts': [{'name': 'Henry Jansen, MD', 'role': 'CONTACT', 'email': 'h.jansen@aig.umcn.nl', 'phone': '0031243611111'}], 'overallOfficials': [{'name': 'Henry Jansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}, {'name': 'Cees Tack, Prof.dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. dr. C. J. Tack', 'oldOrganization': 'Radboud University Nijmegen Medical Centre'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-01-31', 'type': 'RELEASE'}, {'date': '2013-03-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Radboud University Medical Center'}}}}