Bone Health in Youth With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Bone Mineral Accrual and Microarchitecture in Youth With Type 1 Diabetes

Conditions
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Type 1 Diabetes, Osteoporosis

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| youth with type 1 diabetes<br> | |
| healthy controls<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, osteoporosis, children