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Completed

NCT Number: NCT04784975

Bone Health and Microbiome in Persons With Type 1 Diabetes

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.

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Key information

Conditions

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IUSM

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 Exclusion Criteria for Healthy Controls:

  • Presence of any diabetes autoantibody
  • Presence of any type of diabetes or hyperglycemia (HbA1c≥5.7%)

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. High-resolution peripheral quantitative computed tomography (HRpQCT) strength of cortical and trabecular bone.

    Time frame: Through study completion, which is within 12 weeks of visit 1

    Our primary outcome is HRpQCT strength of cortical and trabecular bone.

Secondary outcomes

  1. Dual-energy x-ray absorptiometry (DXA)

    Time frame: Through study completion, which is within 12 weeks of visit 1

    Lumbar spine, hip, and total body less head by DXA

  2. Microbiome

    Time frame: Through study completion, which is within 12 weeks of visit 1

    Gut microbiome profile

  3. Glycemia

    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)

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Bone Health and Gut Microbiome in Persons With Preclinical and Clinical Type 1 Diabetes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Feb 28, 2023

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.

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