Effects of Type 1 Diabetes on Fracture Risk and Bone Health
Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk
This study is trying to see how Type 1 diabetes affects bone health and fracture risk in postmenopausal women over 50 who have had diabetes for more than ten years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Creighton University Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT05701254 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the skeletal effects of Type 1 Diabetes Mellitus (T1DM) on the risk of low-trauma fractures in postmenopausal women. It aims to enroll 40 female participants aged 50 and over, who have had diabetes for more than ten years, to undergo transiliac bone biopsies for mechanical testing and tissue analysis. A matched non-diabetic control group will also be included to compare bone density and structural integrity. The study seeks to uncover underlying mechanical defects in bone tissue that may contribute to the increased fracture risk in individuals with T1DM.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 50 and over with Type 1 Diabetes for more than ten years.
Not a fit: Patients with chronic diseases affecting bone health or those not meeting the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into bone health management for patients with Type 1 Diabetes, potentially leading to improved fracture prevention strategies.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated that diabetes significantly impacts bone health, suggesting potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Criteria for enrollment of female diabetics 1. No chronic disease diagnoses that may affect bone, as confirmed by the PI. 2. Normal clinical history, physical, and clinical laboratory exam (except for usual complications of a 10+-year diabetic, i.e., \~minimal neuropathy or retinopathy, known, but asymptomatic mild vascular disease, etc.) 3. Glomelular Filtration Rate (GFR) \>45 ml/min (Renal Association lower limit for "mild" kidney failure). 4. Willingness to sign a consent form. 5. Willingness to undergo a transilial bone biopsy incision that yields 2 bone specimens. 6. No abnormalities in clinical blood chemistry measurements (small, age-related decreases in GFR, will be permitted). 7. Caucasian Criteria for each non-diabetic subject, compared to their matched diabetic: 1. Dual-energy x-ray absorptiometry (DXA) measures (BMD, gm/cm) must be within +/- 15% in total hip. 2. Body mass index (BMI) must be within +/-10%. 3. Age must be within +/- 5 years. 4. Caucasian Exclusion Criteria: 1. Women who have had Type 1 diabetes for less than 10 years. 2. Non-insulin dependent Type 1 diabetic. 3. Less than 50 years old. 4. Less than 5 years post menopausal.
Where this trial is running
Omaha, Nebraska
- Creighton University Osteoporosis Research Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Mohammed Akhter, PhD — Creighton University Osteoporosis Research Center
- Study coordinator: Adam Hornig
- Email: adam.hornig@unmc.edu
- Phone: 402-559-9116
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.