Diabetes Mellitus, Type 1, Bone Fracture, Bone Health
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTClinical tests
The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
DIAGNOSTIC_TESTBiochemical tests
The investigators perform blood and urine tests in every participant.
DIAGNOSTIC_TESTDXA scan
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
DIAGNOSTIC_TESTAGE Reader
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.
Sponsors
CHU de Quebec-Universite Laval
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Individuals with type 1 diabetes Inclusion Criteria: * Diagnosis of type 1 diabetes for at least 5 years; * Age 20 years and older.
Exclusion criteria
* Pregnancy or breastfeeding; * Conditions associated with bone disease (significant liver disease, intestinal malabsorption other than celiac disease, organ transplant, active cancer, rheumatoid arthritis, hyperthyroidism, hypothyroidism with abnormal thyroid-stimulating hormone (TSH), hyperparathyroidism, hypoparathyroidism, acromegaly, Cushing syndrome, adrenal insufficiency); * Any of these medications in the past 6 months : glucocorticoids ≥ 7,5 mg prednisone/day or equivalency ≥ 3 months, aromatase inhibitors, antiandrogens, antiepileptic drugs, anticoagulants, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, thiazolidinediones; * Past medical history of traumatic vertebral fracture; * Inability to consent. Healthy controls Inclusion Criteria: * Age 20 years and older.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vertebral fracture detected with VFA | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Areal bone mineral density of total hip, Z-score | Baseline | Measured by DXA scan |
| Areal bone mineral density of total hip, T-score | Baseline | Measured by DXA scan |
| Areal bone mineral density of distal radius in g/cm2 | Baseline | Measured by DXA scan |
| Areal bone mineral density of distal radius, T-score | Baseline | Measured by DXA scan |
| Areal bone mineral density of distal radius, Z-score | Baseline | Measured by DXA scan |
| Lean mass (arm, leg, trunk, android, gynoid and total) | Baseline | Body composition measured by DXA scan |
| Areal bone mineral density of the spine in g/cm2 | Baseline | Measured by DXA scan |
| Areal bone mineral density of the spine, T-score | Baseline | Measured by DXA scan |
| Areal bone mineral density of the spine, Z-score | Baseline | Measured by DXA scan |
| Areal bone mineral density of proximal femur in g/cm2 | Baseline | Measured by DXA scan |
| Areal bone mineral density of proximal femur, T-score | Baseline | Measured by DXA scan |
| Areal bone mineral density of proximal femur, Z-score | Baseline | Measured by DXA scan |
| Areal bone mineral density of total hip in g/cm2 | Baseline | Measured by DXA scan |
| Fat mass (arm, leg, trunk, android, gynoid and total) | Baseline | Body composition measured by DXA scan |
| Skin AGE measurement | Baseline | Measured by AGE Reader |
| C-telopeptide | Baseline | Bone turnover marker (serum) |
| Sclerostin | Baseline | Bone turnover marker (serum) |
| Osteocalcin | Baseline | Bone turnover marker (serum) |
Other
| Measure | Time frame | Description |
|---|---|---|
| HbA1C | Baseline | Diabetes control marker |
| Hemoglobin | Baseline | Blood level measurement |
| Creatinine | Baseline | Blood level measurement |
| Calcium | Baseline | Blood level measurement |
| Albumine | Baseline | Blood level measurement |
| Phosphate | Baseline | Blood level measurement |
| 25-Hydroxyvitamin D | Baseline | Blood level measurement |
| Parathormone (PTH) | Baseline | Blood level measurement |
| Insulin like growth factor-1 (IGF-1) | Baseline | Blood level measurement |
| Antitransglutaminase antibodies | Baseline | Blood level measurement |
| Immunoglobulin A (IgA) | Baseline | Blood level measurement |
| Follicle stimulating hormone (FSH, women) | Baseline | Blood level measurement |
| Total testosterone (men) | Baseline | Blood level measurement |
| Sex hormone-binding globulin (SHBG, men) | Baseline | Blood level measurement |
| Microalbuminuria | Baseline | Urine microalbuminuria / urine creatinine ratio measurement |
| Thyroid-stimulating hormone (TSH) | Baseline | Blood level measurement |
| Lipid panel | Baseline | Blood level measurement |
Countries
Canada
Outcome results
None listed