RecruitingNCT05701254

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

Sponsor

Creighton University

Enrollment

80 participants

Start Date

Jun 18, 2019

Study Type

OBSERVATIONAL

Conditions

Fractures, Bone Type 1 Diabetes Osteopenia Bone Loss

Summary

Patients with Type 1 Diabetes Mellitus (T1DM) have a higher risk of low-trauma (osteoporotic) fracture that is 7-12 times higher than non-diabetics. The bone density of people with Type 1 Diabetes is higher at the time of fracture than in non-diabetics. This suggests the presence of underlying bone tissue mechanical defects. The potential benefits to participants would be knowledge gained about their bone density and the results of laboratory tests. On a wider scale, there may be general benefits to society because the knowledge gained from this study may help better understand the effects of diabetes on bone health

Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study examines how type 1 diabetes affects bone strength and fracture risk. Researchers will collect and analyze bone biopsies and blood tests from women with long-standing type 1 diabetes and compare them to women without diabetes to understand what makes diabetic bones more fragile. **You may be eligible if...** - You are a Caucasian woman with type 1 diabetes of 10 or more years - You have only minor complications from diabetes (mild neuropathy or retinopathy, known mild vascular disease) and otherwise normal health - Your kidney function is adequate (GFR above 45 mL/min) - You are willing to undergo a small bone biopsy from the hip area **You may NOT be eligible if...** - You have other chronic diseases that affect bone health - You have abnormal blood chemistry beyond what is expected with diabetes - You are not willing to undergo the bone biopsy procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETransilial bone biopsy

The transiliac bone biopsy will be performed on each subject under local anesthesia, and conscious sedation. From one skin incision located \~2cm posterior and inferior to the anterior-superior pelvic spine on one side of the pelvis, the investigators will obtain two iliac bone specimens, each 7.5 mm in diameter, cylindrical in shape, and including both inner and outer cortices and the intervening trabecular bone.