Clinical trial NCT02140424: Bone Health in Youth With Type 1 Diabetes
Official title: Bone Mineral Accrual and Microarchitecture in Youth With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Osteoporosis
Keywords: type 1 diabetes
osteoporosis
children
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-05-16
Enrollment: 242
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: youth and young adults with type 1 diabetes and healthy controls

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Rate of bone mineral accrual
timeFrame: 0, 12, 24 months
Secondary outcomes:
measure: Cross-sectional comparison of bone microarchitectural parameters in patients with diabetes vs. controls
timeFrame: Baseline
measure: Rate of bone mineral accrual
timeFrame: 0 and 24 months
measure: Change bone microarchitectural parameters in patients with diabetes vs. controls
timeFrame: 0 and 24 months
Other outcomes:
measure: Association of glycemic control with bone mineral accrual
timeFrame: 0 and 24 months
measure: Association of bone mineral accrual with moderate-to-vigorous physical activity
timeFrame: 0 and 24 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Deborah M Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.