protocolSection identificationModule nctId: NCT06351176, orgStudyIdInfo id: 2024-6819, briefTitle: Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes, acronym: DenSiFy cohort, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-07-04, primaryCompletionDateStruct date: 2024-12-22, completionDateStruct date: 2025-08-29, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: CHU de Quebec-Universite Laval, class: OTHER, collaborators name: Diabetes Canada, descriptionModule briefSummary: Background : Type 1 diabetes (T1D) is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. As T1D is often diagnosed in childhood or early adulthood, the lower bone mineral density (BMD) and deteriorated bone microarchitecture observed in T1D may reflect changes in the bone that occurred before or at the time of peak bone mass achievement. There is a lack of high-quality prospective studies to determine whether adults with T1D continue to lose BMD or deteriorate bone quality compared with controls. Moreover, while chronic hyperglycemia is a risk factor for fracture in T1D, it is unknown if better glycemic control affects bone outcomes.This prospective multicenter cohort study aims: (1) To compare the changes in the following outcomes over 4 years in adults with T1D and controls without diabetes of similar age, sex and body-mass index distribution: BMD by dual-energy X-ray absorptiometry (DXA) at the femoral neck, hip, spine, and radius, trabecular bone score (TBS) by DXA, and serum biochemical markers of bone turnover (BTMs); (2) To evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in BMD and TBS in people with T1D., conditionsModule conditions: Diabetes Mellitus, Type 1, conditions: Bone Health, conditions: Bone Loss, conditions: Bone Diseases, Metabolic, conditions: Hyperglycaemia Due to Type 1 Diabetes Mellitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 163, type: ESTIMATED, armsInterventionsModule interventions name: Clinical tests, interventions name: Biochemical tests, interventions name: DXA scan with TBS and VFA, interventions name: AGEReader, outcomesModule primaryOutcomes measure: Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2, secondaryOutcomes measure: Change in areal bone mineral density (aBMD) at the spine in g/cm2, secondaryOutcomes measure: Change in areal bone mineral density (aBMD) at the total hip in g/cm2, secondaryOutcomes measure: Change in areal bone mineral density (aBMD) at the distal third of radius in g/cm2, secondaryOutcomes measure: Change in Trabecular bone score (TBS) (unitless), secondaryOutcomes measure: Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years, secondaryOutcomes measure: Glycemic control, assessed with skin advanced glycation end products (AGEs), secondaryOutcomes measure: Presence of a microvascular complication (neuropathy, nephropathy, retinopathy), otherOutcomes measure: Areal bone mineral density at the femoral neck, g/cm2, otherOutcomes measure: Areal bone mineral density at the femoral neck, T-Score, otherOutcomes measure: Areal bone mineral density at the femoral neck, Z-Score, otherOutcomes measure: Areal bone mineral density at the total hip, g/cm2, otherOutcomes measure: Areal bone mineral density at the total hip, T-score, otherOutcomes measure: Areal bone mineral density at the total hip, Z-score, otherOutcomes measure: Areal bone mineral density at the spine, g/cm2, otherOutcomes measure: Areal bone mineral density at the spine, T-Score, otherOutcomes measure: Areal bone mineral density at the spine, Z-score, otherOutcomes measure: Areal bone mineral density at the distal third of radius, g/cm2, otherOutcomes measure: Areal bone mineral density at the distal third of radius, T-score, otherOutcomes measure: Areal bone mineral density at the distal third of radius, Z-score, otherOutcomes measure: Trabecular bone score (TBS) at the lumbar spine (L1-L4) (unitless), otherOutcomes measure: Vertebral Fracture Assessment (VFA) from the T4 to L5 vertebrae to detect the presence of vertebral fracture, otherOutcomes measure: Lean mass (arm, leg, trunk, android, gynoid and total) (g), otherOutcomes measure: Fat mass (arm, leg, trunk, android, gynoid and total) (g), otherOutcomes measure: C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL), otherOutcomes measure: Procollagen type 1 N-terminal propeptide (P1NP) (ng/mL), otherOutcomes measure: Osteocalcin (ng/mL), otherOutcomes measure: Sclerostin (pmol/mL), otherOutcomes measure: Change in C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL), otherOutcomes measure: Change in osteocalcin (ng/mL), otherOutcomes measure: Change in procollagen type 1 N-terminal propeptide (P1NP) (ng/mL), otherOutcomes measure: Change in sclerostin (pmol/mL), otherOutcomes measure: Skin advanced glycation end-products (AGEs) (arbitrary units), otherOutcomes measure: Glycated hemoglobin (HbA1c, %), otherOutcomes measure: Fasting glucose (mmol/L), otherOutcomes measure: Complete blood count, otherOutcomes measure: Thyroid-stimulating hormone (TSH) (mU/L), otherOutcomes measure: Lipid panel (total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol/HDL-cholesterol ratio, triglycerides, in mmol/L), otherOutcomes measure: Creatinine (umol/L), otherOutcomes measure: Microalbuminuria (mg/mmol), otherOutcomes measure: Liver enzymes (AST, ALT) (U/L), otherOutcomes measure: Calcium (mmol/L), otherOutcomes measure: Albumine (g/L), otherOutcomes measure: Phosphate (mmol/L), otherOutcomes measure: 25-hydroxyvitamin D3 (nmol/L), otherOutcomes measure: Parathormone (PTH) (ng/L), otherOutcomes measure: Antitransglutaminase antibodies (U/mL), otherOutcomes measure: Immunoglobulin A (IgA) (g/L), otherOutcomes measure: Insulin like growth factor-1 (IGF-1) (ng/mL), otherOutcomes measure: Follicle stimulating hormone (FSH, women) (U/L), otherOutcomes measure: Total testosterone (men) (nmol/L), otherOutcomes measure: Sex hormone-binding globulin (SHBG, men) (nmol/L), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut de recherches cliniques de Montréal (IRCM), city: Montréal, state: Quebec, zip: H2W 1R7, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Centre de recherche du CHU de Québec-Université Laval, city: Quebec City, state: Quebec, zip: G1V 4G2, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False