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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Creighton University
Study ID
NCT05701254
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Transilial bone biopsy — PROCEDURE
    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.

Study Details

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

Key Dates

Start date
Jun 18, 2019
Status verified
Sep 2024
Primary completion
Dec 31, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Creighton University Osteoporosis Research CenterOmahaNebraska68122
Adam Hornig
[email protected]
402-559-9116
Mohammed Akhter, PhD
[email protected]
402-280-5019
Laura Armas, MD (SUB_INVESTIGATOR)
Mohammed Akhter, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Omaha, NE

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Creighton University Osteoporosis Research Center· Omaha, NE

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