Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT04093856
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2019-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D058866', 'term': 'Osteoporotic Fractures'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], '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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2019-09-13', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle size measured as cross-sectional muscle area at the proximal femur', 'timeFrame': 'Baseline', 'description': 'Measured by quantitative computed tomography (QCT)'}, {'measure': 'Muscle composition measured as muscle fat content at the proximal femur', 'timeFrame': 'Baseline', 'description': 'Measured by quantitative computed tomography (QCT)'}, {'measure': 'Volumetric bone mineral density (vBMD) at the spine, hip, radius and tibia', 'timeFrame': 'Baseline', 'description': 'Measured by quantitative computed tomography (QCT)'}], 'secondaryOutcomes': [{'measure': 'N-terminal propeptide of type 1 procollagen concentration', 'timeFrame': 'Baseline', 'description': 'Serum bone formation marker'}, {'measure': 'Osteocalcin (total and decarboxylated) concentration', 'timeFrame': 'Baseline', 'description': 'Serum bone formation marker'}, {'measure': 'Bone specific alkaline phosphatase concentration', 'timeFrame': 'Baseline', 'description': 'Serum bone formation marker'}, {'measure': 'C-telopeptide concentration', 'timeFrame': 'Baseline', 'description': 'Serum bone resorption marker'}, {'measure': 'Fasting glucose concentration', 'timeFrame': 'Baseline', 'description': 'Diabetes control'}, {'measure': 'Fasting Hemoglobin A1c concentration', 'timeFrame': 'Baseline', 'description': 'Diabetes control'}, {'measure': 'Insulin concentration', 'timeFrame': 'Baseline', 'description': 'Hormone involved in bone metabolism'}, {'measure': 'Serum 25-hydroxyvitamin D concentration', 'timeFrame': 'Baseline', 'description': 'Hormone involved in bone metabolism'}, {'measure': 'Parathormone concentration', 'timeFrame': 'Baseline', 'description': 'Hormone involved in bone metabolism'}, {'measure': 'Estradiol concentration', 'timeFrame': 'Baseline', 'description': 'Hormone involved in bone metabolism'}, {'measure': 'Insulin like growth factor-1 concentration', 'timeFrame': 'Baseline', 'description': 'Hormone involved in bone metabolism'}, {'measure': 'Sclerostin concentration', 'timeFrame': 'Baseline', 'description': 'Hormone involved in bone metabolism'}, {'measure': 'Adiponectin concentration', 'timeFrame': 'Baseline', 'description': 'Hormone involved in bone metabolism'}, {'measure': 'Leptin concentration', 'timeFrame': 'Baseline', 'description': 'Hormone involved in bone metabolism'}, {'measure': 'Body composition measured as visceral and subcutaneous adipose tissue', 'timeFrame': 'Baseline', 'description': 'Measured by computed tomography (CT)'}, {'measure': 'Body composition measured by fat and lean mass', 'timeFrame': 'Baseline', 'description': 'Measured using dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Bone marrow adiposity', 'timeFrame': 'Baseline', 'description': 'Measured by computed tomography (CT)'}, {'measure': 'Upper extremity muscle strength measured by grip force in kg', 'timeFrame': 'Baseline', 'description': 'Measured using Jamar Hydraulic Hand Dynamometer'}, {'measure': 'Lower extremity muscle strength measured by peak torque generated by knee extension', 'timeFrame': 'Baseline', 'description': 'Measured using Biodex isokinetic dynamometer'}, {'measure': 'Functional mobility measured by time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.', 'timeFrame': 'Baseline', 'description': 'Measured using Timed Up and Go test.'}, {'measure': 'Functional exercise capacity measured by total distance ambulated during a 6 minute time period', 'timeFrame': 'Baseline', 'description': 'Measured using Six Minute Walk Test'}, {'measure': 'Self-reported physical activity measured in metabolic equivalents (MET)', 'timeFrame': 'Baseline', 'description': 'Measured using the International Physical Activity Questionnaire'}, {'measure': 'Cutaneous Advanced glycation end products (AGEs) measurement', 'timeFrame': 'Baseline', 'description': 'Measured by measured by AGE Reader'}, {'measure': 'Physical activity measured by total activity and time spent in different intensities of exercise measured over 7 consecutive days', 'timeFrame': 'Baseline', 'description': 'Actigraph GT3X+ Accelerometer'}, {'measure': 'Functional balance score obtained using multidimensional balance assessment. Higher scores indicate better balance abilities', 'timeFrame': 'Baseline', 'description': 'Fullerton Advanced Balance (FAB) Scale'}, {'measure': 'Physical health', 'timeFrame': 'Baseline', 'description': 'SF-12'}, {'measure': 'Community Participation Restriction', 'timeFrame': 'Baseline', 'description': 'Life-space mobility assessment'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Baseline', 'description': 'How are you today? Visual analogue scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced glycation end products', 'Advanced imaging', 'Mobility', 'Strength'], 'conditions': ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Obesity', 'Body Weight', 'Bone Diseases, Metabolic', 'Fractures, Bone', 'Osteoporotic Fractures', 'Osteoporosis', 'Quality of Life', 'Fall', 'Musculoskeletal Diseases']}, 'descriptionModule': {'briefSummary': 'Background: Osteoporotic fractures are a major public health issue. They cause substantial disability, loss of autonomy, morbidity and excess mortality. Diabetes is also associated with increased risk for falls and fractures through a direct impact of elevated blood glucose on the skeleton and on muscles.\n\nResearch project overview: The investigators propose a cross-sectional study that will involve 2 research centers in the province of Quebec. The investigators will recruit 20 obese participants, without diabetes, who have not undergone bariatric surgery, for one-time measurements to be compared with baseline measurements (pre-surgery) from participants in the bariatric obese diabetic groups with type II diabetes mellitus from the ongoing study BODI study (NCT03455868). Bone Mineral Density as well as muscle quality, strength and function will be evaluated at a single study visit.\n\nRelevance: This data will permit the evaluation of the bone-muscle unit in patients with obesity with and without diabetes, and assess whether the presence and duration of diabetes impacts further on clinical and functional musculoskeletal outcomes (falls, fractures and mobility and strength) in this population. AGEs, if associated with muscle and bone deterioration, might become an easily accessible biomarker of musculoskeletal health in the clinical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a multi-center, cross-sectional, observational study comprising of two groups of participants with obesity either with or without diabetes (n=20/group). The diabetic groups will include 20 adult men and women with obesity and type 2 diabetes, and the non-diabetic group will consist of 20 age- and sex- matched individuals with obesity and normoglycemia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA) Diabetic group\n\n* BMI \\>=35 kg/m2\n* Clinical diagnosis of type 2 diabetes\n* Use of oral hypoglycemic agents or insulin or 2 of the following tests confirming type 2 diabetes: HbA1c \\>=6.5%; fasting glucose \\>=7.0 mM; 2-h glucose post 75g oral glucose tolerance test (OGTT) \\>=11.1 mM)\n\nB) Non-diabetic group:\n\n* BMI \\>=35 kg/m2\n* Normoglycemia (HgbA1c \\<5.7% and Fasting glucose \\<5.6 nM)\n\nExclusion Criteria:\n\n* BMI \\>60 kg/m2\n* Clinical diagnosis of type 1 diabetes\n* Disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance \\<60 ml/min)\n* Medication (e.g. gluccocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism\n* Pregnancy\n* History of oesophageal, gastric, digestive or bariatric surgery\n* Prosthesis that could interfere with interpretation of imaging data\n* Chronic severe condition or illness precluding from participation in the project.'}, 'identificationModule': {'nctId': 'NCT04093856', 'acronym': 'BODI2', 'briefTitle': 'Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes', 'orgStudyIdInfo': {'id': 'MP-37-2020-5872'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic', 'description': '20 men and women with type 2 diabetes and obesity'}, {'label': 'Non-diabetic', 'description': '20 normoglycemic men and women with obesity matched for age and sex with diabetic group'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3H 2R9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Institute of the McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'country': 'Canada', 'facility': "Centre de recherche de l'IUCPQ", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzanne Morin', 'class': 'OTHER'}, 'collaborators': [{'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinician Researcher', 'investigatorFullName': 'Suzanne Morin', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}