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

  • STATUS
    Recruiting
  • days left to enroll
    77
  • participants needed
    80
  • sponsor
    Columbia University
Updated on 19 February 2024
insulin
autoimmune disease
type 1 diabetes mellitus

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.

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/FEA)-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).

Details
Condition Type1diabetes
Age 8-14 years
Clinical Study IdentifierNCT04289727
SponsorColumbia University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Children within 2 years preceding the onset of the pubertal growth spurt
Inclusion Criteria (T1D participants)
documentation of -cell autoimmunity and need for insulin replacement

Exclusion Criteria

Estimated glomerular filtration rate (eGFR)< 60 ml/mim
(OH)D level < 20 ng/ml
Celiac disease
Autoimmune thyroid disease
Addison's disease
History of pathological fractures
\-- Disorders associated with altered skeletal structure or function
Bone active drugs in past year
Diabetes of other or unclear etiology
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