NCT04289727

Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to find out how bones are affected in children and adolescents with type 1 diabetes (T1D) as compared to children and adolescents without type 1 diabetes.

Detailed description

T1D is primarily associated with decrements in bone strength due to disrupted microarchitecture occurring during peak bone mass accrual, and this disruption arises from hyperglycemia and glycemic variability. Impaired bone development during this period likely predisposes to an increased fracture risk across the lifespan. The investigators will compare baseline, 12 month and 24 month changes in High-resolution peripheral quantitative computed tomography/micro-finite element analysis (HR-pQCT/μFEA)-based estimates of bone strength and bone turnover by biochemical measurements in 40 T1D children at the onset of peak bone mineral accretion (n=40) versus sex and puberty-matched healthy controls (n=40). The investigators will determine relationships between changes in bone strength (including trabecular and cortical components) and measures of glycemic control and variability by continuous glucose monitoring (CGM).

Conditions

• Type1diabetes

Timeline

• Start date: 2020-01-01
• Primary completion: 2025-09-08
• Completion: 2025-09-08
• First posted: 2020-02-28
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States