Type1diabetesNCT04784975
Bone Health and Microbiome in Persons With Type 1 Diabetes
An observational study of Type1diabetes, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2021to 23 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Type 1 Diabetes
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Health and Gut Microbiome in Persons With Preclinical and Clinical 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.
Read the 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
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-resolution peripheral quantitative computed tomography (HRpQCT) strength of cortical and trabecular bone.
Our primary outcome is HRpQCT strength of cortical and trabecular bone.
Measured: Through study completion, which is within 12 weeks of visit 1
Secondary outcomes (3)
Dual-energy x-ray absorptiometry (DXA)
Lumbar spine, hip, and total body less head by DXA
Measured: Through study completion, which is within 12 weeks of visit 1
Microbiome
Gut microbiome profile
Measured: Through study completion, which is within 12 weeks of visit 1
Glycemia
Serum Hemoglobin A1C (HbA1c) and Time in Range using a continuous glucose monitor (CGM)
Measured: Through study completion, which is within 12 weeks of visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start23 Apr 2021
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Neyman, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784975
- Sponsor's protocol ID
- BONE
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Health and Gut Microbiome in Persons With Preclinical and Clinical Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04784975
- Acronym / sponsor ID
- BONE
- Conditions
- Type1diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preclinical Type 1 Diabetes | – | Other: No interventionAdolescents 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. |
| New Onset Type 1 Diabetes | – | Other: No interventionAdolescents 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. |
| Long standing Type 1 Diabetes | – | Other: No interventionAdolescents 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. |
| Control | – | Other: No interventionAdolescents 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. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Type 1 Diabetes
Key inclusion criteria (3 listed)
- Willing and able to comply with study protocol
- T1D diagnosed clinically by an endocrinologist as documented in medical records.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Control, Long standing Type 1 Diabetes, New Onset Type 1 Diabetes, Preclinical Type 1 Diabetes |
Primary outcome
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.
3 secondary outcomes
Dual-energy x-ray absorptiometry (DXA)
Time frame: Through study completion, which is within 12 weeks of visit 1
Microbiome
Time frame: Through study completion, which is within 12 weeks of visit 1
Glycemia
Time frame: Through study completion, which is within 12 weeks of visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.