Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT03930758
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2019-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preventing Diabetic Osteoporosis With Exercise
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Study consisted of 5 experimental trials (or arms), of which 4 were compared to a sedentary (or control) arm. The five trials were: Uphill exercise before the meals (UBM), Uphill exercise after the meals (UAM), Downhill exercise before the meals (DBM), and Downhill exercise after the meals (DAM), and the Sedentary (Sed) or control trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2012-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-26', 'studyFirstSubmitDate': '2019-04-19', 'studyFirstSubmitQcDate': '2019-04-26', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-terminal propeptide of type I collagen', 'timeFrame': 'Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial', 'description': 'Change over time in plasma concentration of c-terminal propeptde of type 1 collagen (ng/ml)'}, {'measure': 'C-terminal telopeptide of type 1 collagen', 'timeFrame': 'Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial', 'description': 'Change over time in plasma concentration of c-terminal telopeptide of type 1 collagen (ng/ml)'}, {'measure': 'Osteocalcin', 'timeFrame': 'Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial', 'description': 'Change over time in plasma concentration of osteocalcin (ng/ml)'}, {'measure': 'Bone-specific alkaline phosphatase', 'timeFrame': 'Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial', 'description': 'Change over time in plasma concentration of bone-specific alkaline phosphatase (ng/ml)'}], 'secondaryOutcomes': [{'measure': 'Insulin', 'timeFrame': 'Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial', 'description': 'Change over time in plasma concentration of insulin (µU/ml)'}, {'measure': 'Parathyroid hormone', 'timeFrame': 'Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial', 'description': 'Change over time in plasma concentration of parathyroid hormone (ng/ml)'}, {'measure': 'Cortisol', 'timeFrame': 'Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial', 'description': 'Change over time in plasma concentration of cortisol (m/L)'}, {'measure': 'Growth hormone', 'timeFrame': 'Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial', 'description': 'Change over time in plasma concentration of growth hormone (ng/ml)'}, {'measure': 'Glucose', 'timeFrame': 'Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial', 'description': 'Change over time in plasma concentration of glucose (mg/dl)'}, {'measure': 'Dual-energy X-ray radiography', 'timeFrame': 'A week prior to the study baseline', 'description': 'Whole-body dual-energy X-ray radiography scan'}, {'measure': 'Novel Pedar', 'timeFrame': 'During two one-hour bouts of the exercise intervention', 'description': 'Mechanosensitive shoe inserts for measurement of ground reaction force'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The two specific aims of the study were to determine whether:\n\n1. Greater mechanical loading of downhill exercise will increase the osteogenic index (ratio between CICP, the marker of bone formation (c-terminal propeptide of type I collagen, and CTX, the marker of bone resorption (c terminal telopeptide of type I collagen)) to a greater extent than uphill exercise that provides lower ground-reaction force;\n2. Exercise after the meals will induce greater osteogenic response than exercise pefore the meals as it is known that meal eating during daytime inhibits bvone resorption markers.', 'detailedDescription': 'The study addresses the problem that postmenopausal women with type 2 diabetes have a higher incidence of bone breaks despite their often normal bone mineral density (BMD).\n\nThe investigators pursued two hypotheses, that:\n\n1. 40-minute bout of downhill exercise will increase the CICP/CTX osteogenic index to a greater extent than the same amount of uphill exercise; and\n2. Performing exercise one hour after the meals will be more osteogenic than exercise before the meals.\n\nSubjects were 15 postmenopausal women with type 2 diabetes, age 57.7 years, BMI 27.2 kg/m2 who were randomly assigned to two out of 5 trials:\n\nUphill exercise before the meals (UBM), Uphill exercise after the meals (UAM), Downhill exercise before the meals (DBM), Downhill exercise after the meals (DAM), and Sedentary, no-exercise, trial (SED). All subjects signed an informed consent approved by the University of Michigan Medical School Institutional Review Board. Subjects had their BMD measured with DXA at the outset.\n\nWeight-maintenance meals contained 50% carbohydrate, 15% protein, and 25% fat and were provided at 10 h and 17 h. Exercise (40 minutes at 50% of maximal effort) on either uphill (+6o slope) or downhill treadmill (-6o slope) was performed either before the two meals, at 9 h and 16 h, respectively, or after the meals. at 11 h and 18 h, respectively.\n\nBlood was drawn through an intravenous catheter from ante-cubital vein at hourly intervals between 8 and 20 h with two additional blood draws at 0 h and 6 h the next morning. Blood was treated with protease inhibitors, and plasma, frozen at -80o C, was used to measure bone markers, CICP, CTX, osteocalcin , and bone-specific alkaline phosphatase using Millipore chemoluminescen reagents, glucose by glucose oxidase, and hormones insulin, cortisol, parathyroid hormone (PTH) , and growth hormone (GH) by radio-immunoassays..\n\nMixed-model ANOVA was used for analysis of outcome measures where the trial procedures served as fixed variable and individual subjects as intercept variables.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npostmenopausal type-2 diabetes melllitus age between 50 and 65 exercise less than 20 minutes three times a week\n\nExclusion Criteria:\n\nmetabolic disease other than type-2 diabetes and hormonally-corrected hypothyroidism musculo-skeletal disability that would preclude exercise smoker do not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03930758', 'acronym': 'DIABETICBONE', 'briefTitle': 'Preventing Diabetic Osteoporosis With Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'HUM32227/ HUM32700'}, 'secondaryIdInfos': [{'id': 'R15DK082800', 'link': 'https://reporter.nih.gov/quickSearch/R15DK082800', 'type': 'NIH'}, {'id': 'M01RR024986', 'type': 'OTHER_GRANT', 'domain': 'Michigan Institute of Clinical and Health Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Uphill exercise before the meals', 'description': '40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal', 'interventionNames': ['Combination Product: Behavior intervention of uphill exercise', 'Combination Product: Dietary intervention of exercise before the meal']}, {'type': 'EXPERIMENTAL', 'label': 'Uphill exercise after the meals', 'description': '40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal', 'interventionNames': ['Combination Product: Dietary intervention of uphill exercise', 'Combination Product: Dietary intervention of exercise after the meal']}, {'type': 'EXPERIMENTAL', 'label': 'Downhill exercise before the meals', 'description': '40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal', 'interventionNames': ['Combination Product: Behavior intervention of downhill exercise', 'Combination Product: Dietary intervention of exercise before the meal']}, {'type': 'EXPERIMENTAL', 'label': 'Downhill exercise after the meals', 'description': '40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal', 'interventionNames': ['Combination Product: Behavioral intervention of downhill exercise', 'Combination Product: Dietary intervention of exercise after the meal']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sedentary trial', 'description': 'A trial with no exercise', 'interventionNames': ['Combination Product: Behavioral intervention of sedentary no-exercise trial', 'Combination Product: Dietary intervention of eating two meals']}], 'interventions': [{'name': 'Behavior intervention of uphill exercise', 'type': 'COMBINATION_PRODUCT', 'description': '40 minutes of uphill exercise', 'armGroupLabels': ['Uphill exercise before the meals']}, {'name': 'Dietary intervention of exercise before the meal', 'type': 'COMBINATION_PRODUCT', 'description': '40 minutes of uphill exercise completed 1 h before the meal', 'armGroupLabels': ['Uphill exercise before the meals']}, {'name': 'Dietary intervention of uphill exercise', 'type': 'COMBINATION_PRODUCT', 'description': '40 minutes of uphill exercise', 'armGroupLabels': ['Uphill exercise after the meals']}, {'name': 'Dietary intervention of exercise after the meal', 'type': 'COMBINATION_PRODUCT', 'description': '40 minutes of uphill exercise started 1 hour after gthe meal', 'armGroupLabels': ['Uphill exercise after the meals']}, {'name': 'Behavior intervention of downhill exercise', 'type': 'COMBINATION_PRODUCT', 'description': '40 minutes of downhill exercise', 'armGroupLabels': ['Downhill exercise before the meals']}, {'name': 'Dietary intervention of exercise before the meal', 'type': 'COMBINATION_PRODUCT', 'description': '40 minutes of downhill exercise completed 1 hour before the meal', 'armGroupLabels': ['Downhill exercise before the meals']}, {'name': 'Behavioral intervention of downhill exercise', 'type': 'COMBINATION_PRODUCT', 'description': '40 minutes of downhill exercise', 'armGroupLabels': ['Downhill exercise after the meals']}, {'name': 'Dietary intervention of exercise after the meal', 'type': 'COMBINATION_PRODUCT', 'description': '40 minutes of downhill exercise started 1 hour after the meal', 'armGroupLabels': ['Downhill exercise after the meals']}, {'name': 'Behavioral intervention of sedentary no-exercise trial', 'type': 'COMBINATION_PRODUCT', 'description': 'Sedentary no-exercise trial', 'armGroupLabels': ['Sedentary trial']}, {'name': 'Dietary intervention of eating two meals', 'type': 'COMBINATION_PRODUCT', 'description': 'Meals eaten at 10 and 17 h during a sedentary trial', 'armGroupLabels': ['Sedentary trial']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Katarina T Borer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor Emerita'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Wisconsin, La Crosse', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Katarina Borer', 'investigatorAffiliation': 'University of Michigan'}}}}