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

Recruiting

• Conditions: Type1diabetes

• Registration Number: NCT04289727
• Lead Sponsor: Columbia University

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-19
• Last Update Posted: 2024-05-21
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Columbia University Medical Center-Harkness Pavillion; 🇺🇸 New York, New York, United States