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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: t
View:

⁃ Criteria for enrollment of female diabetics

• No 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).

• Caucasian

⁃ Criteria 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.

• Caucasian

Locations
United States
Nebraska
Creighton University Osteoporosis Research Center
RECRUITING
Omaha
Contact Information
Primary
Adam Hornig
adam.hornig@unmc.edu
402-559-9116
Backup
Laura Armas, M.D.
laura.armas@unmc.edu
402-559-8700
Time Frame
Start Date: 2019-06-18
Estimated Completion Date: 2025-01
Participants
Target number of participants: 80
Treatments
Type 1 Diabetics
All participants will complete 4 visits over 6-8 weeks. Visit 1 is a screening visit which includes a physical exam, a bone mineral density scan, a blood draw and an EKG. Visit 2 consists of dispensing the Tetracycline antibiotic required for the bone biopsy. Visit 3 is the bone biopsy and includes a blood draw. Visit 4 is to remove the stitches.
Non-Type 1 Diabetics
All participants will complete 4 visits over 6-8 weeks. Visit 1 is a screening visit which includes a physical exam, a bone mineral density scan, a blood draw and an EKG. Visit 2 consists of dispensing the Tetracycline antibiotic required for the bone biopsy. Visit 3 is the bone biopsy and includes a blood draw. Visit 4 is to remove the stitches.
Related Therapeutic Areas
Sponsors
Leads: Creighton University

This content was sourced from clinicaltrials.gov