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OpenTrials
Completed

NCT Number: NCT04289727

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

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.

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Key information

Conditions

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center-Harkness Pavillion

New York, 10032, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in microarchitecture by HR-pQCT

    Time frame: Two Years

    Measures of HRpQCT

  2. Change in bone mineral density by Dual X-ray Absorptometry (DXA)

    Time frame: Two Years

    Measures of DXA

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2020
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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