Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT02140424

Conditions

Type 1 Diabetes

Osteoporosis

Eligibility Criteria

Sex: All

Age: 6 - 20

Healthy Volunteers: Accepted

Study Details

Brief 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. 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

Study ID

NCT02140424

Start date

Aug, 2013

Status verified date

Oct, 2020

Completion date

Jul, 2024

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 20

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

242 participants

Anticipated

Interventions and Outcome Measures

Arms

youth with type 1 diabetes

healthy controls

Primary outcome measure

  • Rate of bone mineral accrual [ Time Frame: 0, 12, 24 months ]

Central Contacts and Locations

Central contacts

Deborah M Mitchell, MD

617-724-2034dmmitchell@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Deborah M Mitchell, MD

617-724-2034dmmitchell@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 9, 2020

Last verified

Oct, 2020

Keywords

  • type 1 diabetes
  • osteoporosis
  • children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2020-10-09.