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Background : Type 1 diabetes is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. The lower bone mineral density (BMD) observed in individuals with type 1 diabetes cannot solely explain the higher fracture incidence. Bone microarchitecture defects significantly contribute to bone fragility. Few studies assessed spine fractures in type 1 diabetes.
This cross-sectional multicenter case-control study aims (1) to evaluate the prevalence of asymptomatic vertebral fractures in individuals with type 1 diabetes in comparison to age- and sex-matched healthy controls; (2) to compare individuals with diabetes with vertebral fractures and those without vertebral fracture using clinical, biochemical and radiological parameters.
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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 |
|---|---|---|
| Vertebral fracture detected with VFA | Vertebral Fracture Assessment (VFA) software of dual-energy X-ray absorptiometry (DXA scan) is used to identify vertebral fractures. If there is evidence of a vertebral fracture on VFA, a lateral and anteroposterior spine X-ray will be obtained to confirm the VFA results. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Areal bone mineral density of the spine in g/cm2 | Measured by DXA scan | Baseline |
| Areal bone mineral density of the spine, T-score | Measured by DXA scan |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1C | Diabetes control marker | Baseline |
| Hemoglobin | Blood level measurement | Baseline |
Individuals with type 1 diabetes
Inclusion Criteria:
Exclusion Criteria:
Healthy controls
Inclusion Criteria:
Exclusion Criteria:
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127 individuals with type 1 diabetes and 64 healthy subjects
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Gagnon, Dr | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35090169 | Result | Coll JC, Garceau E, Leslie WD, Genest M, Michou L, Weisnagel SJ, Mac-Way F, Albert C, Morin SN, Rabasa-Lhoret R, Gagnon C. Prevalence of Vertebral Fractures in Adults With Type 1 Diabetes: DenSiFy Study (Diabetes Spine Fractures). J Clin Endocrinol Metab. 2022 Apr 19;107(5):e1860-e1870. doi: 10.1210/clinem/dgac031. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood (serum and plasma)
| Clinical tests | Diagnostic Test | The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant. |
|
| Biochemical tests | Diagnostic Test | The investigators perform blood and urine tests in every participant. |
|
| DXA scan | Diagnostic Test | The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant. |
|
| AGE Reader | Diagnostic Test | The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant. |
|
| Baseline |
| Areal bone mineral density of the spine, Z-score | Measured by DXA scan | Baseline |
| Areal bone mineral density of proximal femur in g/cm2 | Measured by DXA scan | Baseline |
| Areal bone mineral density of proximal femur, T-score | Measured by DXA scan | Baseline |
| Areal bone mineral density of proximal femur, Z-score | Measured by DXA scan | Baseline |
| Areal bone mineral density of total hip in g/cm2 | Measured by DXA scan | Baseline |
| Areal bone mineral density of total hip, T-score | Measured by DXA scan | Baseline |
| Areal bone mineral density of total hip, Z-score | Measured by DXA scan | Baseline |
| Areal bone mineral density of distal radius in g/cm2 | Measured by DXA scan | Baseline |
| Areal bone mineral density of distal radius, T-score | Measured by DXA scan | Baseline |
| Areal bone mineral density of distal radius, Z-score | Measured by DXA scan | Baseline |
| Lean mass (arm, leg, trunk, android, gynoid and total) | Body composition measured by DXA scan | Baseline |
| Fat mass (arm, leg, trunk, android, gynoid and total) | Body composition measured by DXA scan | Baseline |
| Skin AGE measurement | Measured by AGE Reader | Baseline |
| C-telopeptide | Bone turnover marker (serum) | Baseline |
| Sclerostin | Bone turnover marker (serum) | Baseline |
| Osteocalcin | Bone turnover marker (serum) | Baseline |
| Creatinine | Blood level measurement | Baseline |
| Lipid panel | Blood level measurement | Baseline |
| Thyroid-stimulating hormone (TSH) | Blood level measurement | Baseline |
| Calcium | Blood level measurement | Baseline |
| Albumine | Blood level measurement | Baseline |
| Phosphate | Blood level measurement | Baseline |
| 25-Hydroxyvitamin D | Blood level measurement | Baseline |
| Parathormone (PTH) | Blood level measurement | Baseline |
| Insulin like growth factor-1 (IGF-1) | Blood level measurement | Baseline |
| Antitransglutaminase antibodies | Blood level measurement | Baseline |
| Immunoglobulin A (IgA) | Blood level measurement | Baseline |
| Follicle stimulating hormone (FSH, women) | Blood level measurement | Baseline |
| Total testosterone (men) | Blood level measurement | Baseline |
| Sex hormone-binding globulin (SHBG, men) | Blood level measurement | Baseline |
| Microalbuminuria | Urine microalbuminuria / urine creatinine ratio measurement | Baseline |
| Québec |
| G1V 4G2 |
| Canada |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014947 | Wounds and Injuries |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |