Impact of Type 1 Diabetes on Bone Strength in Children
Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength
This study looks at how type 1 diabetes affects bone strength in children and teens by comparing them to healthy kids over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 8 Years to 14 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04289727 on ClinicalTrials.gov |
What this trial studies
This research investigates how type 1 diabetes affects bone strength in children and adolescents compared to their healthy peers. The study will assess changes in bone strength and turnover over 24 months using advanced imaging techniques and continuous glucose monitoring. By comparing 40 children with type 1 diabetes to 40 matched controls, the study aims to understand the relationship between glycemic control and bone health during critical growth periods.
Who should consider this trial
Good fit: Ideal candidates include children diagnosed with type 1 diabetes who are within two years of the onset of their pubertal growth spurt.
Not a fit: Patients with conditions affecting bone structure or function, such as celiac disease or a history of pathological fractures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing bone health in children with type 1 diabetes.
How similar studies have performed: While there is ongoing research into the effects of diabetes on bone health, this specific approach using advanced imaging techniques in a pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Columbia University Medical Center-Harkness Pavillion — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mishaela Rubin, MD — Columbia University
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.