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It is well-established that persons with type 1 diabetes (T1D) are at an increased risk for morbidity and mortality related to bone fracture due to poor bone health, however we do not fully understand the mechanism behind the increased fracture risk. We are examining bone health and the microbiome in adolescents and young adults with type 1 diabetes to better understand the reasons behind this increased risk.
This pilot study aims to look at measures of bone health, the gut microbiome and measures of glycemia/glycemic variability in those with preclinical and clinical diabetes. Our primary and secondary outcomes are to characterize these variables, with our long term objectives to better understand the natural history of bone health in T1D, help characterize the etiology of worse bone health in those with T1D, and try to identify potential time periods for intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preclinical Type 1 Diabetes | Adolescents and young adults with preclinical diabetes (having at least 2 positive diabetes autoantibodies but who do not meet criteria for clinical diagnosis of type 1 diabetes). There is no intervention. Each group will complete a bone health assessment, a microbiome assessment and a glycemic assessment with the goal of better understanding the association between these different variables and bone health. |
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| New Onset Type 1 Diabetes | Adolescents and young adults with a diagnosis of clinical type 1 diabetes. There is no intervention. Each group will complete a bone health assessment, a microbiome assessment and a glycemic assessment with the goal of better understanding the association between these different variables and bone health. |
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| Long standing Type 1 Diabetes | Adolescents and young adults with type 1 diabetes for at least 2 years. There is no intervention. Each group will complete a bone health assessment, a microbiome assessment and a glycemic assessment with the goal of better understanding the association between these different variables and bone health. |
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| Control | Adolescents and young adults without any evidence of diabetes or hyperglycemia. There is no intervention. Each group will complete a bone health assessment, a microbiome assessment and a glycemic assessment with the goal of better understanding the association between these different variables and bone health. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| High-resolution peripheral quantitative computed tomography (HRpQCT) strength of cortical and trabecular bone. | Our primary outcome is HRpQCT strength of cortical and trabecular bone. | Through study completion, which is within 12 weeks of visit 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Dual-energy x-ray absorptiometry (DXA) | Lumbar spine, hip, and total body less head by DXA | Through study completion, which is within 12 weeks of visit 1 |
| Microbiome | Gut microbiome profile |
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Inclusion Criteria:
- Willing and able to comply with study protocol
For participants with type 1 diabetes (T1D):
- T1D diagnosed clinically by an endocrinologist as documented in medical records.
Exclusion Criteria:
Additional Exclusion Criteria for Healthy Controls:
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Type 1 Diabetes
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IUSM | Indianapolis | Indiana | 46202 | United States |
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| Through study completion, which is within 12 weeks of visit 1 |
| Glycemia | Serum Hemoglobin A1C (HbA1c) and Time in Range using a continuous glucose monitor (CGM) | Through study completion, which is within 12 weeks of visit 1 |