Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk

Launched by CREIGHTON UNIVERSITY · Jan 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how Type 1 diabetes affects bone health, particularly the risk of fractures from low-impact activities. People with Type 1 diabetes are known to have a much higher chance of breaking bones compared to those without diabetes, even when their bone density seems normal at the time of the fracture. The researchers hope to learn more about the underlying issues with bone structure that might lead to these fractures. By participating, you could gain valuable information about your own bone density and overall health, which could also help improve our understanding of diabetes and bone health in the larger community.

To be eligible for this study, you need to be a female aged 18 to 62 with Type 1 diabetes for at least 10 years. You should not have any other chronic diseases affecting your bones, and your kidney function should be normal or only mildly affected. You'll need to be willing to undergo a minor surgical procedure to take small samples of your bone for testing. If you decide to participate, you can expect to undergo several tests and assessments to help researchers gather the information they need. Your involvement could contribute to important discoveries about diabetes and its effects on bone strength.

Gender

FEMALE

Eligibility 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.