Status:
COMPLETED
Bone Health and Microbiome in Persons With Type 1 Diabetes
Lead Sponsor:
Indiana University
Conditions:
Type1diabetes
Eligibility:
All Genders
12-20 years
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...
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 ou...
Eligibility Criteria
Inclusion
- \- 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
- 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%)
Key Trial Info
Start Date :
April 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 23 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04784975
Start Date
April 23 2021
End Date
September 23 2022
Last Update
February 28 2023
Active Locations (1)
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1
IUSM
Indianapolis, Indiana, United States, 46202