Type1diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Indiana University
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
Yes
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
* use of oral or parenteral antibiotics within 3 months * use of probiotics/prebiotics/synbiotics within 3 months of enrollment; persons who eat yogurt will be asked to stop for 30 days prior to stool collection * use of medications that will affect bone, including glucocorticoids, bisphosphonates * chronic medications (other than insulin for those with T1D or a stable dose of thyroid hormone) * uncontrolled chronic gastrointestinal disease including celiac disease (persons with T1D will be screened for celiac disease with a Tissue Transglutaminase Antibody (tTG)/Immunoglobulin A (IgA) if not done in prior 2 years) * known genetic syndrome that predisposes the participant to fracture (such as osteogenesis imperfect) or skeletal dysplasia that would affect skeletal assessment (such as hypochondroplasia) * pregnancy * Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or would make it unlikely the subject could complete the study Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High-resolution peripheral quantitative computed tomography (HRpQCT) strength of cortical and trabecular bone. | Through study completion, which is within 12 weeks of visit 1 | Our primary outcome is HRpQCT strength of cortical and trabecular bone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dual-energy x-ray absorptiometry (DXA) | Through study completion, which is within 12 weeks of visit 1 | Lumbar spine, hip, and total body less head by DXA |
| Microbiome | Through study completion, which is within 12 weeks of visit 1 | Gut microbiome profile |
| Glycemia | Through study completion, which is within 12 weeks of visit 1 | Serum Hemoglobin A1C (HbA1c) and Time in Range using a continuous glucose monitor (CGM) |
Countries
United States
Outcome results
None listed