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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| youth with type 1 diabetes | |||
| healthy controls |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 and 24 months |
Inclusion Criteria:
Exclusion Criteria:
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youth and young adults with type 1 diabetes and healthy controls
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah M Mitchell, MD | Contact | 617-724-2034 | dmmitchell@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Deborah M Mitchell, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32929477 | Derived | Joseph TV, Caksa S, Misra M, Mitchell DM. Hip Structural Analysis Reveals Impaired Hip Geometry in Girls With Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4848-56. doi: 10.1210/clinem/dgaa647. | |
| 31761940 | Derived | Mitchell DM, Caksa S, Joseph T, Bouxsein ML, Misra M. Elevated HbA1c Is Associated with Altered Cortical and Trabecular Microarchitecture in Girls with Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1648-56. doi: 10.1210/clinem/dgz221. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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serum, plasma, urine
| 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. | 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. | 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. | 0 and 24 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |