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

Columbia University

Status

Completed

Conditions

Type1diabetes

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT04289727

R01DK122564 (U.S. NIH Grant/Contract)

AAAS5630

Details and patient eligibility

About

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.

Full 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).

Enrollment

86 patients

Sex

All

Ages

8 to 14 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (T1D and Controls):

- Children within 2 years preceding the onset of the pubertal growth spurt

Inclusion Criteria (T1D participants):

- documentation of β-cell autoimmunity and need for insulin replacement

Exclusion Criteria:

Estimated glomerular filtration rate (eGFR)< 60 ml/mim
25(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