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

NCT ID: NCT04289727

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-09-08

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).

Conditions

Type1diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Those with Type 1 Diabetes.

No interventions assigned to this group

Group 2

Those without Type 1 Diabetes.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Mishaela Rubin

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mishaela Rubin, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center-Harkness Pavillion

New York, New York, United States

Countries

United States

Other Identifiers

R01DK122564

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAS5630

Identifier Type: -

Identifier Source: org_study_id