Bone Health and Microbiome in Persons With Type 1 Diabetes

NCT ID: NCT04784975

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2022-09-23

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.

Conditions

Type1diabetes

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Preclinical Type 1 Diabetes

Adolescents and young adults with preclinical diabetes (having at least 2 positive diabetes autoantibodies but who do not meet criteria for clinical diagnosis of type 1 diabetes).

There is no intervention. Each group will complete a bone health assessment, a microbiome assessment and a glycemic assessment with the goal of better understanding the association between these different variables and bone health.

No intervention

Intervention Type: OTHER

No intervention

New Onset Type 1 Diabetes

Adolescents and young adults with a diagnosis of clinical type 1 diabetes. There is no intervention. Each group will complete a bone health assessment, a microbiome assessment and a glycemic assessment with the goal of better understanding the association between these different variables and bone health.

No intervention

Intervention Type: OTHER

No intervention

Long standing Type 1 Diabetes

Adolescents and young adults with type 1 diabetes for at least 2 years. There is no intervention. Each group will complete a bone health assessment, a microbiome assessment and a glycemic assessment with the goal of better understanding the association between these different variables and bone health.

No intervention

Intervention Type: OTHER

No intervention

Control

Adolescents and young adults without any evidence of diabetes or hyperglycemia. There is no intervention. Each group will complete a bone health assessment, a microbiome assessment and a glycemic assessment with the goal of better understanding the association between these different variables and bone health.

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Anna Neyman

Assistant Professor of Clinical Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IUSM

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

BONE

Identifier Type: -

Identifier Source: org_study_id