Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT03455868
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood (serum and plasma)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-03-05', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bone microarchitecture and metabolism', 'timeFrame': 'during surgery', 'description': 'by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry'}, {'measure': 'Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5)', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'Using the algorithm-based qualitative method (ABQ) and the Genant method'}, {'measure': 'Prevalence and incidence of falls', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'by questionnaire'}, {'measure': 'Prevalence and incidence of non-vertebral fractures', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'by questionnaire (self-reported)'}], 'primaryOutcomes': [{'measure': 'Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, tibia and radius', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'assessed by quantitative computed tomography (QCT)'}, {'measure': 'Change in areal bone mineral density at lumbar spine, hip and radius', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'assessed by dual-energy X-ray absorptiometry (DXA)'}], 'secondaryOutcomes': [{'measure': 'Change in N-terminal propeptide of type 1 procollagen (P1NP)', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'serum bone formation marker'}, {'measure': 'Change in osteocalcin (total, gamma-carboxylated and and under-carboxylated)', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'serum bone formation marker'}, {'measure': 'Change in bone alkaline phosphatase', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'serum bone formation marker'}, {'measure': 'Change in C-telopeptide', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'serum bone resorption marker'}, {'measure': 'Change in fasting glucose', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'diabetes control'}, {'measure': 'Change in HbA1c', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'diabetes control'}, {'measure': 'Change in fasting insulin', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in serum 25-hydroxyvitamin D', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in parathormone (PTH)', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in estradiol and estrone', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in insulin like growth factor (IGF)-1', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in sclerostin', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in adiponectin', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in leptin', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in peptide YY (PYY)', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in ghrelin', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in oxidative stress markers', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in serum advanced glycation end products (AGEs)', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in Free fatty acids (FFA)', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'hormones involved in bone metabolism'}, {'measure': 'Change in fat and lean mass', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'body composition assessed by bioimpedance and by DXA'}, {'measure': 'Change in visceral and subcutaneous adipose tissue', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'body composition assessed by computed tomography (CT)'}, {'measure': 'Change in muscle mass and fat content at mid-femur', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'assessed by computed tomography (CT)'}, {'measure': 'Change in upper extremity muscle strength', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'assessed by hand grip strength'}, {'measure': 'Change in lower extremity muscle strength', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'assessed by knee extensor strength'}, {'measure': 'Change in muscle function', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'assessed by timed up and go test'}, {'measure': 'Change in physical capacity', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'assessed by 6-minute walk test'}, {'measure': 'Change in balance', 'timeFrame': 'before and 1 year after bariatric surgery', 'description': 'assessed by Fullerton Advanced Balance (FAB) Scale'}, {'measure': 'Change in sociodemographic factors', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'questionnaire'}, {'measure': 'Change in nutrition', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': '3 web-based 24-h recalls'}, {'measure': 'Change in self-reported physical activity level', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'by questionnaire'}, {'measure': 'Change in measured physical activity level', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'by accelerometer'}, {'measure': 'Change in gut microbiota', 'timeFrame': 'before, 1 year after and 3 years after bariatric surgery', 'description': 'stool sample'}, {'measure': 'Change in cutaneous Advanced glycation end products (AGEs)', 'timeFrame': 'before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery', 'description': 'skin autofluorescence'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery', 'Bone Health', 'Obesity, Morbid', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Background: Bone fragility is a complication of type 2 diabetes. Diabetes treatments may ameliorate or deteriorate bone fragility in this population. Bariatric surgery is gaining in popularity in people with type 2 diabetes and may impact bone health. Objectives: To evaluate the impact of the most popular bariatric procedure worldwide (sleeve gastrectomy (SG)) on vBMD by QCT in patients with type 2 diabetes; Secondary aims: (1) to identify the determinants of vBMD after bariatric surgery in patients with type 2 diabetes; (2) to compare vBMD and its potential determinants after bariatric surgery with obese controls without diabetes as well as with controls without obesity and normoglycemia.', 'detailedDescription': 'This is a multicentre, prospective and observational study comprising a bariatric group with or without diabetes undergoing SG (n=70) and one control group (n=30).\n\nOutcome measures are assessed before and at 4 months, 8 months, one year and 3 years after surgery in the bariatric groups and at a single visit for the control group.\n\nBariatric groups will include adult men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy and followed at 0, 4 months, 8 months, 1 year and 3 years after surgery, and the control group will consist of 30 overweight individuals (10 men, 10 premenopausal women, 10 menopausal women) and without diabetes or prediabetes and assessed at a single visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is a multicentre, prospective and observational study comprising a bariatric group with or without diabetes undergoing SG (n=70) and one control group (n=30).\n\nBariatric groups will include adult men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy and followed at 0, 4 months, 8 months, 1 year and 3 years after surgery, and the control group will consist of 30 overweight individuals (10 men, 10 premenopausal women, 10 menopausal women) and without diabetes or prediabetes and assessed at a single visit.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bariatric groups: men and women; 18 to 60 years old; with a BMI \\>=35 kg/m2; with type 2 diabetes: 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) (guidelines.diabetes.ca);) or without diabetes: HbA1c \\<6.5% AND fasting glucose \\<7.0 mM; who are awaiting bariatric surgery. Control group: BMI 25.0 to 29.9 kg/m2 (overweight group); without diabetes or prediabetes: HbA1c \\<6.0% AND fasting glucose \\<6.1 mM (Diabetes Canada criteria), with a stable weight for the last 3 months.\n\nExclusion Criteria:\n\n* bariatric groups: type 1 diabetes; disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance \\<60 ml/min) or medication (e.g. glucocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism; BMI\\>60 kg/m2; CT scan impossible to perform (e.g. patient too large for the gantry aperture); pregnant women or women who plan to become pregnant during the study or women of childbearing age who do not agree to take an appropriate contraceptive method during the study; history of oesophageal, gastric or digestive surgery; history of bariatric surgery; cancer at risk of recurrence during the study; Prosthesis that could interfere with interpretation of imaging data; Chronic severe condition or illness precluding from participation in the project.\n\nControl group: Same criteria plus: \\>5% change in weight in the last 3 months; pregnancy or lactation in the last year.'}, 'identificationModule': {'nctId': 'NCT03455868', 'acronym': 'BODI', 'briefTitle': 'Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'MP-10-2018-2957'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sleeve gastrectomy diabetes', 'description': '70 Men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy', 'interventionNames': ['Procedure: Bariatric surgery']}, {'label': 'Control without obesity or diabetes', 'description': '30 Men and women who are overweight (without obesity) and without diabetes'}], 'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'description': 'Sleeve gastrectomy', 'armGroupLabels': ['Sleeve gastrectomy diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3H 2R9', 'city': 'Montreal', 'state': 'Quebec', 'status': 'TERMINATED', 'country': 'Canada', 'facility': 'The Research Institute of the McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G2', 'city': 'Québec', 'state': 'Quebec', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Centre de recherche du CHU de Québec - Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sarah Chouinard-Castonguay', 'role': 'CONTACT', 'email': 'Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca', 'phone': '4185254444', 'phoneExt': '48729'}, {'name': 'Gagnon Claudia, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre de recherche de l'IUCPQ", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Sarah Chouinard-Castonguay', 'role': 'CONTACT', 'email': 'Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca', 'phone': '4185254444', 'phoneExt': '48729'}], 'overallOfficials': [{'name': 'Claudia Gagnon, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Québec - Université Laval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'collaborators': [{'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Claudia Gagnon', 'investigatorAffiliation': 'CHU de Quebec-Universite Laval'}}}}