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

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04289727
• Other study ID #: AAAS5630
• Secondary ID: R01DK122564
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Rukshana Majeed, BA
• Phone: 2123059489
• Email: rm3324[@]columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

Inclusion Criteria (T1D and Controls):

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

Inclusion Criteria (T1D participants):

• documentation of ß-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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Locations

Country	Name	City	State
United States	Columbia University Medical Center-Harkness Pavillion	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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