Bone Health and Microbiome in Persons With Type 1 Diabetes

Completed

Conditions studied: Type1diabetes

In brief

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.

Key facts

Study ID

NCT04784975

Run by

Indiana University

People needed

26

Starts

2021-04-23

Expected to finish

2022-09-23

Last updated by the study team

2023-02-28

Who can join

Age: 12 and older, up to 20. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 Exclusion Criteria for Healthy Controls:
• Presence of any diabetes autoantibody
• Presence of any type of diabetes or hyperglycemia (HbA1c≥5.7%)

Where it is running

• IUSM — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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