Bone Health in Youth With Type 1 Diabetes

NCT ID: NCT02140424

Last Updated: 2020-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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youth with type 1 diabetes

No interventions assigned to this group

healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 6-20 years
* Out of honeymoon period (cohort with diabetes)

Exclusion Criteria

* 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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Deborah Mitchell, MD

Assistant Professor in Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah M Mitchell, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Deborah M Mitchell, MD

Role: CONTACT

617-724-2034

Facility Contacts

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Deborah M Mitchell, MD

Role: primary

617-724-2034

References

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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.

Reference Type DERIVED
PMID: 32929477 (View on PubMed)

Mitchell 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.

Reference Type DERIVED
PMID: 31761940 (View on PubMed)

Other Identifiers

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2013P000985

Identifier Type: -

Identifier Source: org_study_id

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