Observational Study on Bone Health in Type 1 Diabetes

This observational study is looking into why women with Type 1 Diabetes (T1DM) are more likely to experience bone fractures, even when their bone density seems normal. Researchers believe there might be problems with the bone tissue itself. The study will compare bone tissue from 40 women, aged 50 and older, who have had T1DM for over ten years, with bone tissue from healthy women without diabetes. Each participant will undergo a transilial bone biopsy (a procedure to take a small sample of hip bone) to analyze specific markers in the bone. The goal is to understand how T1DM affects bone health and potentially help develop better ways to prevent fractures in the future. You might gain knowledge about your own bone density and lab test results.

Study design
This is an observational study involving 80 participants in total: 40 women with Type 1 Diabetes and 40 healthy women without diabetes.
What's involved
You would undergo a transilial bone biopsy, which involves taking two small samples of hip bone under local anesthesia and conscious sedation.
Compensation
Not stated in the trial record.
Follow-up
Bone tissue levels will be measured at 6-8 weeks after the biopsy.

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NCT05701254

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

Recruiting
Not specifiedAges 50+Observational
Creighton University
~80 participants
Updated 2024-09-25 on ClinicalTrials.gov
What's tested:Transilial bone biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare cortical bone tissue levels of pentosidine (AGE), pyridinoline (normal enzymatic collagen crosslinks), and matrix-bound water between T1DM and controls.
Measured over 6-8 weeks
Type 1 Diabetes
Osteopenia
Bone Loss
Fractures, Bone
1 sites across 1 states
Nebraska1
  • Mohammed Akhter, PhD · PRINCIPAL_INVESTIGATOR · Creighton University Osteoporosis Research Center

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  • Compare cortical bone tissue levels of pentosidine (AGE), pyridinoline (normal enzymatic collagen crosslinks), and matrix-bound water between T1DM and controls.6-8 weeks

    For different advance glycation endproducts (AGEs), a) pentosidine (PEN), b) pyrinoline (Pyd), and c) tissue water (TW), will be measured using Raman spectroscopy technique on bone biopsy tissue obtained from study participants. Raman spectra will be obtained from the embedded block surfaces using a confocal Raman spectrometer (Renishaw InVia Qontor, www.renishaw.de). These spectra will be collected at the interstitial, cement lines, and actively bone forming osteons with evident fluorescent labels. A continuous laser beam with an excitation of 785 nm and power of 10 mW will be focused through a Raman microscope (Leica DM2700M), using the 50x objective, down to a micrometer-sized spot on the sample. 1. Pentosidine (PEN) \[ratio\]. PEN (Pentosidine) from the integrated area ratio of bands 1495 (PEN) cm-1 / 1450 cm-1 (methylene side chains (CH2)). 2. Pyrinoline (Pyd) \[ratio\]. The pyridinoline (Pyd; enzymatic trivalent collagen cross-link) content is calculated as the absorbance height