Bone Health in Youth With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Bone Mineral Accrual and Microarchitecture in Youth With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02140424
• Other study ID #: 2013P000985
• Status: Recruiting
• Start date: August 2013
• Est. completion date: July 2024

Study information

• Verified date: October 2020
• Source: Massachusetts General Hospital
• Contact: Deborah M Mitchell, MD
• Phone: 617-724-2034
• Email: dmmitchell[@]partners.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Osteoporosis
• Type 1 Diabetes

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association of glycemic control with bone mineral accrual	Glycemic control will be assessed by hemoglobin A1c measurements at study visits and as part of routine diabetes care. An average hemoglobin A1c over the time of observation will be calculated using the trapezoidal rule. Association of glycemic control with bone mineral accrual as measured by DXA will be examined via regression analysis.	0 and 24 months
Other	Association of bone mineral accrual with moderate-to-vigorous physical activity	activity will be assessed with accelerometers. The association of bone accrual among youth with and without diabetes will be assessed by correlation analysis.	0 and 24 months
Primary	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.	0, 12, 24 months
Secondary	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.	Baseline
Secondary	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.	0 and 24 months
Secondary	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.	0 and 24 months