Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT01870557
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2013-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'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': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum Plasma EDTA Plasma Heparin Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'urine creatinine albumin ratio', 'timeFrame': 'Baseline', 'description': 'Collected by both 24 hour urine samples and a urine sample.'}], 'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Baseline', 'description': 'Long term blood glucose evaluation'}, {'measure': 'Bone Mineral Density (t-score)', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Biochemical Bone Markers', 'timeFrame': 'Baseline'}, {'measure': 'Sex-hormones', 'timeFrame': 'Baseline'}, {'measure': 'Electrolytes', 'timeFrame': 'Baseline'}, {'measure': 'Vitamin D (25ODH /1,25OHD)', 'timeFrame': 'Baseline'}, {'measure': 'Results from the HRpQCT scan including Trabecular and Cortical state', 'timeFrame': 'Baseline', 'description': 'Not available for participants at center Aalborg'}, {'measure': 'Markers of fat tissue and glycemic status', 'timeFrame': 'Baseline', 'description': 'Including Insulin level, adiponectin'}, {'measure': 'Verterbral fracture assessment', 'timeFrame': 'Baseline', 'description': 'A part of the DXA if vertebral fracture assessment is available. For patients at center Aalborg this will be evaluated through X-ray.'}, {'measure': 'Lifestyle and Medical history', 'timeFrame': 'Baseline', 'description': 'Assessed by structured interview and questionnaire. Information on alcohol consumption, smoking, pharmaceutical use, diabetes complications, diabetes duration, physical activity, previous fractures are collected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Bone', 'Bone Status', 'Glycemic Markers', 'Osteoporosis', 'Osteopenia'], 'conditions': ['Diabetes Mellitus', 'Osteoporosis', 'Osteopenia']}, 'referencesModule': {'references': [{'pmid': '33790870', 'type': 'DERIVED', 'citation': 'Starup-Linde JK, Viggers R, Langdahl B, Gregersen S, Lykkeboe S, Handberg A, Vestergaard P. Associations of Circulating Osteoglycin With Bone Parameters and Metabolic Markers in Patients With Diabetes. Front Endocrinol (Lausanne). 2021 Mar 15;12:649718. doi: 10.3389/fendo.2021.649718. eCollection 2021.'}, {'pmid': '26756117', 'type': 'DERIVED', 'citation': 'Starup-Linde J, Lykkeboe S, Gregersen S, Hauge EM, Langdahl BL, Handberg A, Vestergaard P. Bone Structure and Predictors of Fracture in Type 1 and Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Mar;101(3):928-36. doi: 10.1210/jc.2015-3882. Epub 2016 Jan 12.'}, {'pmid': '26555635', 'type': 'DERIVED', 'citation': 'Starup-Linde J, Lykkeboe S, Gregersen S, Hauge EM, Langdahl BL, Handberg A, Vestergaard P. Differences in biochemical bone markers by diabetes type and the impact of glucose. Bone. 2016 Feb;83:149-155. doi: 10.1016/j.bone.2015.11.004. Epub 2015 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'Objective To collate the bone status in type 1 and type 2 diabetics using biochemical markers and bone scans.\n\nMethods:\n\nThis is a multicenter trial involving the University Hospitals of three major danish cities: Aalborg, Aarhus and Odense. The trial is of cross-sectional design and consists of examinations including:\n\n* Blood samples to analyze bone markers, glycemic state, kidney function and sex-hormones.\n* 24 hour urine sample to analyze bone markers and kidney function.\n* Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure.\n\nParticipants:\n\n100 type 1 diabetics and 100 type 2 diabetics recruited from outpatient clinics at Aalborg, Aarhus and Odense, general practitioners and flyers.', 'detailedDescription': 'Diabetes Mellitus and Osteoporosis are common conditions. Patients with Diabetes Mellitus are known to have more fractures than their non-diabetic counterparts. However bone mineral density (BMD) which is the most commonly used measure of fracture risk seems to be insensitive in diabetes, thus BMD is lowered in type 1 diabetes but not enough to explain an almost seven fold in fracture risk. BMD is increased in type 2 diabetes although they still have an increased fracture risk.\n\nThe investigators investigate this paradox in diabetes by assessing type 1 and type 2 diabetes patients bone status by blood- and urine samples (assessing markers of bone- and glycemic state) and two types of bone scans comprising of DXA and HRpQCT scan.\n\nThe diabetes mellitus patients are recruited from outpatients clinics in the three study sites (Aalborg, Aarhus and Odense) as well as general practitioners and by flyers and adds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '200 Diabetes Mellitus patients. 100 with type 1 diabetes and 100 with type 2 diabetes. Of the 100 type 2 diabetes patients half should be treated with insulin (n=50) and the other half treated with other oral antidiabetics and not insulin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 or type 2 diabetes.\n* Age ≥ 50 years.\n* Unaltered treatment of diabetes during the previous six months (no changes in drugs, but an increase or decrease in dose is accepted) and HbA1c is stable with a level of ± 1 in the same period.\n* HbA1c level≥ 7 % through the previous six months.\n* BMI between 19 og 35.\n\nSpecific inclusion criteria for type 2 diabetes:\n\n* Either treatment with metformin, sulfonylureas, dipeptidyl peptidase IV (DPP IV) inhibitors or glucagon-like peptide 1 (GLP-1) analogs.\n* Treatment with insulin and insulin in the combination with metformin, sulfonylureas, DPP IV inhibitors or GLP-1 analogs.\n\nExclusion Criteria:\n\n* HbA1C \\> 10%\n* Pregnancy.\n* Metal implanted at both ankles and wrists.\n* Patients treated with: Antiresorptive (incl. hormone replacement therapy) or bone anabolic treatment, glucocorticoids, lithium and anticonvulsives.\n* Patients with a bone disease other than osteoporosis.\n* Vertebral fracture visible by vertebral fracture assessment (VFA).\n* Patients with renal disease defined by estimated glomerular filtration rate(eGFR) \\< 50.\n* Other medical disease in unstable phase (fx. cancer, hyperthyroidism).\n* Heart failure; New York Heart Association (NYHA) class IV.\n* Patients which the investigator does not believe is fit to participate in the study'}, 'identificationModule': {'nctId': 'NCT01870557', 'acronym': 'Diabone', 'briefTitle': 'Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Markers of Bone Status in Diabetes Mellitus (Type 1 and Type 2)', 'orgStudyIdInfo': {'id': '36777'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes Mellitus type 1', 'description': 'n=100'}, {'label': 'Diabetes Mellitus type 2', 'description': 'n=100'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Department of Endocrinology, Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Peter Vestergaard, Professor MD PhD DrMedSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}, {'name': 'Kim Brixen, Professor MD PhD DrMedSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}, {'name': 'Søren Gregersen, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Bente Lomholt Langdahl, Professor MD PhD DrMedSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Ellen-Magrethe Hauge, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jakob Starup Linde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jakob Starup Linde', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}