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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK122564 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this research study is to find out how bones are affected in children and adolescents with type 1 diabetes (T1D) as compared to children and adolescents without type 1 diabetes.
T1D is primarily associated with decrements in bone strength due to disrupted microarchitecture occurring during peak bone mass accrual, and this disruption arises from hyperglycemia and glycemic variability. Impaired bone development during this period likely predisposes to an increased fracture risk across the lifespan.
The investigators will compare baseline, 12 month and 24 month changes in High-resolution peripheral quantitative computed tomography/micro-finite element analysis (HR-pQCT/μFEA)-based estimates of bone strength and bone turnover by biochemical measurements in 40 T1D children at the onset of peak bone mineral accretion (n=40) versus sex and puberty-matched healthy controls (n=40). The investigators will determine relationships between changes in bone strength (including trabecular and cortical components) and measures of glycemic control and variability by continuous glucose monitoring (CGM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Those with Type 1 Diabetes. | ||
| Group 2 | Those without Type 1 Diabetes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in microarchitecture by HR-pQCT | Measures of HRpQCT | Two Years |
| Change in bone mineral density by Dual X-ray Absorptometry (DXA) | Measures of DXA | Two Years |
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Inclusion Criteria (T1D and Controls):
- Children within 2 years preceding the onset of the pubertal growth spurt
Inclusion Criteria (T1D participants):
- documentation of β-cell autoimmunity and need for insulin replacement
Exclusion Criteria:
Estimated glomerular filtration rate (eGFR)< 60 ml/mim
25(OH)D level < 20 ng/ml.
Celiac disease
Autoimmune thyroid disease
Addison's disease
History of pathological fractures
-- Disorders associated with altered skeletal structure or function
Bone active drugs in past year
Diabetes of other or unclear etiology
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40 children and adolescents between the age of 8 to 14 years with type 1 diabetes and 40 children and adolescents between the age of 8 to 14 years without type 1 diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Mishaela Rubin, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center-Harkness Pavillion | New York | New York | 10032 | United States |
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am fasting Comprehensive Metabolic Panel (CMP) including liver function, HbA1c and 25OHD.