Type 1 DiabetesNCT02140424
Bone Health in Youth With Type 1 Diabetes
An observational study of Type 1 Diabetes and Osteoporosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is an observational study of children and young adults ages 6-20 years with type 1 diabetes and age- and race-matched controls. The investigators will be examining blood and urine hormone levels as well as measures of bone density including DXA and high-resolution peripheral quantitiative computed tomography. Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Osteoporosis
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2024
- 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 6 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: youth and young adults with type 1 diabetes and healthy controls
Who may be able to join
- Age 6-20 years
- Out of honeymoon period (cohort with diabetes)
Who cannot join
- BMI<5th percentile for age
- BMI>95th percentile for age
- Celiac disease
- Hyperthyroidism, uncontrolled hypothyroidism
- History of significant hepatic disease, renal disease, oncologic disease, cardiovascular disease, psychiatric disease
- Anemia (Hgb <11)
- Taking medications other than insulin known to affect bone health (including hormonal contraception, glucocorticoids, growth hormone)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Deborah M Mitchell, MD, 617-724-2034, dmmitchell@partners.org
About this study
Official title: Bone Mineral Accrual and Microarchitecture in Youth With Type 1 Diabetes
This is an observational study of children and young adults ages 6-20 years with type 1 diabetes and age- and race-matched controls. The investigators will be examining blood and urine hormone levels as well as measures of bone density including DXA and high-resolution peripheral quantitiative computed tomography. The investigators will also be collecting data regarding physical activity via use of wearable accelerometers. The investigators hypothesize that youth with type 1 diabetes will have slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic controls, and that bones of individuals with type 1 diabetes will not respond as well to physical activity. The investigators hypothesize that poor bone accrual will be associated with sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.
- Conditions
- Type 1 Diabetes, Osteoporosis
- Keywords
- type 1 diabetes, osteoporosis, children
- Medical subject headings
- Diabetes Mellitus, Type 1, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| youth with type 1 diabetes | Not described | |
| healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of bone mineral accrual
Bone mineral mass and density will be measured by dual-energy x-ray absorptiometry (DXA) at baseline and 12 months. Percent change over time will be calculated and then compared in subjects with type 1 diabetes and matched control subjects.
Measured: 0, 12, 24 months
Secondary outcomes (3)
Cross-sectional comparison of bone microarchitectural parameters in patients with diabetes vs. controls
Bone microarchitecture will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT). Parameters measured will include cortical compartment density, cortical thickness, cortical porosity, trabecular density, trabecular number, and trabecular thickness.
Measured: Baseline
Rate of bone mineral accrual
Bone mineral mass and density will be measured by dual-energy x-ray absorptiometry (DXA) at baseline and 24 months. Percent change over time will be calculated and then compared in subjects with type 1 diabetes and matched control subjects.
Measured: 0 and 24 months
Change bone microarchitectural parameters in patients with diabetes vs. controls
Bone microarchitecture will be assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT) at 0 and 12 months. Parameters measured will include cortical compartment density, cortical thickness, cortical porosity, trabecular density, trabecular number, and trabecular thickness and percent change over 12 months will be calculated. Percent change will be compared in patients with diabetes and matched controls.
Measured: 0 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startAug 2013
- Primary completionJul 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Mitchell, MD, Massachusetts General Hospital
- Investigators
- Deborah M Mitchell, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140424
- Sponsor's protocol ID
- 2013P000985
- Status last verified
- Oct 2020
- First submitted
- 13 May 2014
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Joseph TV, Caksa S, Misra M, Mitchell DM. Hip Structural Analysis Reveals Impaired Hip Geometry in Girls With Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4848-56. doi: 10.1210/clinem/dgaa647.
PubMed 32929477Mitchell DM, Caksa S, Joseph T, Bouxsein ML, Misra M. Elevated HbA1c Is Associated with Altered Cortical and Trabecular Microarchitecture in Girls with Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1648-56. doi: 10.1210/clinem/dgz221.
PubMed 31761940
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Accrual and Microarchitecture in Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02140424
- Acronym / sponsor ID
- 2013P000985
- Conditions
- Type 1 Diabetes, Osteoporosis
- Keywords
- type 1 diabetes, osteoporosis, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2013
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 16 May 2014 (estimated)
- 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.
This is an observational study of children and young adults ages 6-20 years with type 1 diabetes and age- and race-matched controls. The investigators will be examining blood and urine hormone levels as well as measures of bone density including DXA and high-resolution peripheral quantitiative computed tomography. The investigators will also be collecting data regarding physical activity via use of wearable accelerometers. The investigators hypothesize that youth with type 1 diabetes will have slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic controls, and that bones of individuals with type 1 diabetes will not respond as well to physical activity. The investigators hypothesize that poor bone accrual will be associated with sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| youth with type 1 diabetes | – | – |
| healthy controls | – | – |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- youth and young adults with type 1 diabetes and healthy controls
Key inclusion criteria (2 listed)
- Age 6-20 years
- Out of honeymoon period (cohort with diabetes)
Key exclusion criteria (7 listed)
- BMI<5th percentile for age
- BMI>95th percentile for age
- Celiac disease
- Hyperthyroidism, uncontrolled hypothyroidism
- History of significant hepatic disease, renal disease, oncologic disease, cardiovascular disease, psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of bone mineral accrual
Time frame: 0, 12, 24 months
Bone mineral mass and density will be measured by dual-energy x-ray absorptiometry (DXA) at baseline and 12 months. Percent change over time will be calculated and then compared in subjects with type 1 diabetes and matched control subjects.
3 secondary outcomes
Cross-sectional comparison of bone microarchitectural parameters in patients with diabetes vs. controls
Time frame: Baseline
Rate of bone mineral accrual
Time frame: 0 and 24 months
Change bone microarchitectural parameters in patients with diabetes vs. controls
Time frame: 0 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Derived from this study: PubMed 32929477Joseph TV, Caksa S, Misra M, Mitchell DM. Hip Structural Analysis Reveals Impaired Hip Geometry in Girls With Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4848-56. doi: 10.1210/clinem/dgaa647.
- Derived from this study: PubMed 31761940Mitchell DM, Caksa S, Joseph T, Bouxsein ML, Misra M. Elevated HbA1c Is Associated with Altered Cortical and Trabecular Microarchitecture in Girls with Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1648-56. doi: 10.1210/clinem/dgz221.
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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.
Deborah M Mitchell, MD principal investigator
Massachusetts General Hospital
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 Type 1 Diabetes and Osteoporosis, run by Massachusetts General Hospital 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deborah M Mitchell, MD (617-724-2034, dmmitchell@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of bone mineral accrual (time frame: 0, 12, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140424, which also lists 2 linked publications.
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 9 Oct 2020.