Status:
RECRUITING
Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type1diabetes
Eligibility:
All Genders
8-14 years
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 vari...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04289727
Start Date
January 1 2020
End Date
December 1 2025
Last Update
May 14 2025
Active Locations (1)
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1
Columbia University Medical Center-Harkness Pavillion
New York, New York, United States, 10032