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NCT05701254
Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk
Conditions: Type 1 Diabetes, Osteoporosis
Sex: Female
Ages: 50 Years – N/A
Healthy volunteers: 1
Enrollment: 80
Sponsor: Creighton University
Location: United States
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 Criteria
Inclusion Criteria:Criteria for enrollment of female diabeticsNo chronic disease diagnoses that may affect bone, as confirmed by the PI.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.)Glomelular Filtration Rate (GFR) >45 ml/min (Renal Association lower limit for "mild" kidney failure).Willingness to sign a consent form.Willingness to undergo a transilial bone biopsy incision that yields 2 bone specimens.No abnormalities in clinical blood chemistry measurements (small, age-related decreases in GFR, will be permitted).CaucasianCriteria for each non-diabetic subject, compared to their matched diabetic:Dual-energy x-ray absorptiometry (DXA) measures (BMD, gm/cm) must be within +/- 15% in total hip.Body mass index (BMI) must be within +/-10%.Age must be within +/- 5 years.CaucasianExclusion Criteria:Women who have had Type 1 diabetes for less than 10 years.Non-insulin dependent Type 1 diabetic.Less than 50 years old.Less than 5 post menopausal.nd
have had diabetes for at least 10 years.
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Source: ClinicalTrials.gov (NCT05701254). StuddyBuddy aggregates publicly available trial information.