Bone Health in Youth With Type 1 Diabetes

Mass General Brigham

Status: Enrolling

Conditions: Osteoporosis; Type 1 Diabetes

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02140424

2013P000985

Details and patient eligibility

About

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.

Enrollment: 242 estimated patients

Sex: All

Ages: 6 to 20 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

242 participants in 2 patient groups

youth with type 1 diabetes

healthy controls