IUSM
Indianapolis, Indiana, 46202, United States
NCT Number: NCT04784975
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.
Looking for future studies?
Notify Me12 year–20 year
All sexes
Observational
Indianapolis, Indiana, 46202, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For participants with type 1 diabetes (T1D):
Exclusion criteria
Additional Exclusion Criteria for Healthy Controls:
No intervention
Time frame: Through study completion, which is within 12 weeks of visit 1
Our primary outcome is HRpQCT strength of cortical and trabecular bone.
Time frame: Through study completion, which is within 12 weeks of visit 1
Lumbar spine, hip, and total body less head by DXA
Time frame: Through study completion, which is within 12 weeks of visit 1
Gut microbiome profile
Time frame: 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)
Indiana University
Other
Bone Health and Gut Microbiome in Persons With Preclinical and Clinical Type 1 Diabetes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03761186
Autoimmune Diseases, Diabetes Mellitus
Stockholm, Sweden
View Trial DetailsNCT05557227
Glucose Metabolism Disorders, Hyperglycemia
Aarhus, Region Midt, Denmark
View Trial DetailsNCT06115616
Type1diabetes
Aarhus, Denmark
View Trial DetailsNCT05662267
Autoimmune Diseases, Chronic Disease
Lille, France
View Trial Details