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| Name | Class |
|---|---|
| Diabetes Canada | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with type 1 diabetes |
| ||
| Healthy controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical tests | Diagnostic Test | The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2 | aBMD measured by DXA scan | Between the baseline and the 4-year visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in areal bone mineral density (aBMD) at the spine in g/cm2 | aBMD measured by DXA scan | Between the baseline and the 4-year visit |
| Change in areal bone mineral density (aBMD) at the total hip in g/cm2 |
| Measure | Description | Time Frame |
|---|---|---|
| Areal bone mineral density at the femoral neck, g/cm2 | Measured by DXA scan | 4-year visit |
| Areal bone mineral density at the femoral neck, T-Score | Measured by DXA scan |
Individuals with type 1 diabetes who have participated in the DenSiFy (Diabetes Spine Fractures) study (NCT04064437)
Inclusion Criteria:
Exclusion Criteria:
Healthy controls who have participated in the DenSiFy (Diabetes Spine Fractures) study (NCT04064437)
Inclusion Criteria:
Exclusion Criteria :
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127 individuals with type 1 diabetes and 65 healthy subjects from the DenSiFy (Diabetes Spine Fractures) study (NCT04064437)
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Gagnon, MD | CHU de Québec- Université Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de recherches cliniques de Montréal (IRCM) | Montreal | Quebec | H2W 1R7 | Canada | ||
| Centre de recherche du CHU de Québec-Université Laval |
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Blood (serum and plasma)
| Biochemical tests | Diagnostic Test | The investigators perform blood and urine tests in every participant. |
|
| DXA scan with TBS and VFA | Diagnostic Test | The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) including trabecular bone score (TBS) and Vertebral Fracture Assessment (VFA) in every participant. |
|
| AGEReader | Diagnostic Test | The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant. |
|
aBMD measured by DXA scan
| Between the baseline and the 4-year visit |
| Change in areal bone mineral density (aBMD) at the distal third of radius in g/cm2 | aBMD measured by DXA scan | Between the baseline and the 4-year visit |
| Change in Trabecular bone score (TBS) (unitless) | TBS with the software TBSinSight | Between the baseline and the 4-year visit |
| Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years | Mean HbA1c of the past 7 years from all the available HbA1c in the medical record | 4-year visit |
| Glycemic control, assessed with skin advanced glycation end products (AGEs) | Skin AGEs measured with AGEReader (autofluorescence) | 4-year visit |
| Presence of a microvascular complication (neuropathy, nephropathy, retinopathy) | From the information available in the medical record and from monofilament and vibration testing (for neuropathy) and from microalbuminuria (nephropathy) | 4-year visit |
| 4-year visit |
| Areal bone mineral density at the femoral neck, Z-Score | Measured by DXA scan | 4-year visit |
| Areal bone mineral density at the total hip, g/cm2 | Measured by DXA scan | 4-year visit |
| Areal bone mineral density at the total hip, T-score | Measured by DXA scan | 4-year visit |
| Areal bone mineral density at the total hip, Z-score | Measured by DXA scan | 4 year visit |
| Areal bone mineral density at the spine, g/cm2 | Measured by DXA scan | 4-year visit |
| Areal bone mineral density at the spine, T-Score | Measured by DXA scan | 4-year visit |
| Areal bone mineral density at the spine, Z-score | Measured by DXA scan | 4-year visit |
| Areal bone mineral density at the distal third of radius, g/cm2 | Measured by DXA scan | 4-year visit |
| Areal bone mineral density at the distal third of radius, T-score | Measured by DXA scan | 4-year visit |
| Areal bone mineral density at the distal third of radius, Z-score | Measured by DXA scan | 4-year visit |
| Trabecular bone score (TBS) at the lumbar spine (L1-L4) (unitless) | TBS calculated with the software TBSinSight | 4-year visit |
| Vertebral Fracture Assessment (VFA) from the T4 to L5 vertebrae to detect the presence of vertebral fracture | Image acquired by DXA | 4-year visit |
| Lean mass (arm, leg, trunk, android, gynoid and total) (g) | Body composition measured by DXA scan | 4-year visit |
| Fat mass (arm, leg, trunk, android, gynoid and total) (g) | Body composition measured by DXA scan | 4-year visit |
| C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL) | Bone turnover marker, bone resorption (serum) | 4-year visit |
| Procollagen type 1 N-terminal propeptide (P1NP) (ng/mL) | Bone turnover marker, bone formation (serum) | 4-year visit |
| Osteocalcin (ng/mL) | Bone turnover marker, bone formation (serum) | 4-year visit |
| Sclerostin (pmol/mL) | Inhibitor of bone formation (serum) | 4-year visit |
| Change in C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL) | Bone turnover marker, bone resorption (serum) | Between the baseline and the 4-year visit |
| Change in osteocalcin (ng/mL) | Bone turnover marker, bone formation (serum) | Between the baseline and the 4-year visit |
| Change in procollagen type 1 N-terminal propeptide (P1NP) (ng/mL) | Bone turnover marker, bone formation (serum) | Between the baseline and the 4-year visit |
| Change in sclerostin (pmol/mL) | Inhibitor of bone formation (serum) | Between the baseline and the 4-year visit |
| Skin advanced glycation end-products (AGEs) (arbitrary units) | Measured with AGEReader (autofluorescence) | 4-year visit |
| Glycated hemoglobin (HbA1c, %) | Diabetes control marker | 4-year visit |
| Fasting glucose (mmol/L) | Blood level measurement | 4-year visit |
| Complete blood count | Blood level measurement | 4-year visit |
| Thyroid-stimulating hormone (TSH) (mU/L) | Blood level measurement | 4-year visit |
| Lipid panel (total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol/HDL-cholesterol ratio, triglycerides, in mmol/L) | Blood level measurement | 4-year visit |
| Creatinine (umol/L) | Blood level measurement | 4-year visit |
| Microalbuminuria (mg/mmol) | Urine microalbuminuria/ urine creatinine ratio measurement | 4-year visit |
| Liver enzymes (AST, ALT) (U/L) | Blood level measurement | 4-year visit |
| Calcium (mmol/L) | Blood level measurement | 4-year visit |
| Albumine (g/L) | Blood level measurement | 4-year visit |
| Phosphate (mmol/L) | Blood level measurement | 4-year visit |
| 25-hydroxyvitamin D3 (nmol/L) | Blood level measurement | 4-year visit |
| Parathormone (PTH) (ng/L) | Blood level measurement | 4-year visit |
| Antitransglutaminase antibodies (U/mL) | Blood level measurement | 4-year visit |
| Immunoglobulin A (IgA) (g/L) | Blood level measurement | 4-year visit |
| Insulin like growth factor-1 (IGF-1) (ng/mL) | Blood level measurement | 4-year visit |
| Follicle stimulating hormone (FSH, women) (U/L) | Blood level measurement | 4-year visit |
| Total testosterone (men) (nmol/L) | Blood level measurement | 4-year visit |
| Sex hormone-binding globulin (SHBG, men) (nmol/L) | Blood level measurement | 4-year visit |
| Québec |
| Quebec |
| G1V 4G2 |
| Canada |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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