Osteoporosis, Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, osteoporosis, children
Brief summary
This is an observational study of children and young adults ages 6-20 years with type 1 diabetes and age- and race-matched controls. The investigators will be examining blood and urine hormone levels as well as measures of bone density including DXA and high-resolution peripheral quantitiative computed tomography. The investigators will also be collecting data regarding physical activity via use of wearable accelerometers. The investigators hypothesize that youth with type 1 diabetes will have slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic controls, and that bones of individuals with type 1 diabetes will not respond as well to physical activity. The investigators hypothesize that poor bone accrual will be associated with sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.
Interventions
None listed
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 6-20 years * Out of honeymoon period (cohort with diabetes)
Exclusion criteria
* BMI\<5th percentile for age * BMI\>95th percentile for age * Celiac disease * Hyperthyroidism, uncontrolled hypothyroidism * History of significant hepatic disease, renal disease, oncologic disease, cardiovascular disease, psychiatric disease * Anemia (Hgb \<11) * Taking medications other than insulin known to affect bone health (including hormonal contraception, glucocorticoids, growth hormone)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of bone mineral accrual | 0, 12, 24 months | Bone mineral mass and density will be measured by dual-energy x-ray absorptiometry (DXA) at baseline and 12 months. Percent change over time will be calculated and then compared in subjects with type 1 diabetes and matched control subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cross-sectional comparison of bone microarchitectural parameters in patients with diabetes vs. controls | Baseline | Bone microarchitecture will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT). Parameters measured will include cortical compartment density, cortical thickness, cortical porosity, trabecular density, trabecular number, and trabecular thickness. |
| Rate of bone mineral accrual | 0 and 24 months | Bone mineral mass and density will be measured by dual-energy x-ray absorptiometry (DXA) at baseline and 24 months. Percent change over time will be calculated and then compared in subjects with type 1 diabetes and matched control subjects. |
| Change bone microarchitectural parameters in patients with diabetes vs. controls | 0 and 24 months | Bone microarchitecture will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT) at 0 and 12 months. Parameters measured will include cortical compartment density, cortical thickness, cortical porosity, trabecular density, trabecular number, and trabecular thickness and percent change over 12 months will be calculated. Percent change will be compared in patients with diabetes and matched controls. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Association of glycemic control with bone mineral accrual | 0 and 24 months | Glycemic control will be assessed by hemoglobin A1c measurements at study visits and as part of routine diabetes care. An average hemoglobin A1c over the time of observation will be calculated using the trapezoidal rule. Association of glycemic control with bone mineral accrual as measured by DXA will be examined via regression analysis. |
| Association of bone mineral accrual with moderate-to-vigorous physical activity | 0 and 24 months | activity will be assessed with accelerometers. The association of bone accrual among youth with and without diabetes will be assessed by correlation analysis. |
Countries
United States
Contacts
Primary ContactDeborah M Mitchell, MD
Outcome results
None listed