An observational study in Type 1 Diabetes and Osteoporosis, sponsored by Massachusetts General Hospital. Status unknown at 1 site in United States. Open to participants aged 6 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-09.
Sponsored by Massachusetts General Hospital · Observational
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 242 is above the median of 174 across 446 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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youth and young adults with type 1 diabetes and healthy controls
Exclusion Criteria:
Rate of bone mineral accrual
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.
Time frame: 0, 12, 24 months
Cross-sectional comparison of bone microarchitectural parameters in patients with diabetes vs. controls
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.
Time frame: Baseline
Rate of bone mineral accrual
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.
Time frame: 0 and 24 months
Change bone microarchitectural parameters in patients with diabetes vs. controls
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.
Time frame: 0 and 24 months
Association of glycemic control with bone mineral accrual
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.
Time frame: 0 and 24 months
Association of bone mineral accrual with moderate-to-vigorous physical activity
activity will be assessed with accelerometers. The association of bone accrual among youth with and without diabetes will be assessed by correlation analysis.
Time frame: 0 and 24 months
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital