Bone Health and Microbiome in Persons With Type 1 Diabetes

NCT04784975 | Completed DMC

• 1 other identifier: BONE
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (3)

• Dual-energy x-ray absorptiometry (DXA)

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

• Microbiome

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

• Glycemia

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

Study Arms (4)

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.

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.

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.

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Control; Long standing Type 1 Diabetes; New Onset Type 1 Diabetes; Preclinical Type 1 Diabetes

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Type 1 Diabetes

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IUSM

Indianapolis, Indiana, 46202, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 5, 2021
• Study Start: April 23, 2021
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)