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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04289727

Enrollment

Registered

2020-02-28

Start date

2020-01-01

Completion date

2025-09-08

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1diabetes

Brief 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 14 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in microarchitecture by HR-pQCT	Two Years	Measures of HRpQCT
Change in bone mineral density by Dual X-ray Absorptometry (DXA)	Two Years	Measures of DXA

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMishaela Rubin, MD

Columbia University

Outcome results