NCT05701254 Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk
| NCT ID | NCT05701254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Creighton University |
| Condition | Type 1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2019-06-18 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2019-06-18 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Mohammed Akhter, PhD
PRINCIPAL INVESTIGATOR
Creighton University Osteoporosis Research Center
Frequently Asked Questions
Who can join the NCT05701254 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05701254 currently recruiting?
Yes, NCT05701254 is actively recruiting participants. Contact the research team at adam.hornig@unmc.edu for enrollment information.
Where is the NCT05701254 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT05701254 clinical trial?
NCT05701254 is sponsored by Creighton University. The principal investigator is Mohammed Akhter, PhD at Creighton University Osteoporosis Research Center. The trial plans to enroll 80 participants.
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