Menu
Recruiting NCT05701254

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

— Observational Type 1 Diabetes Osteopenia Bone Loss Fractures, Bone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transilial bone biopsy.
Who it may be relevant to
Registry conditions: Type 1 Diabetes, Osteopenia, Bone Loss, Fractures, Bone. Basic parameters: from 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

The investigators will enroll 40 female, postmenopausal, patients with T1DM, fracturing or non-fracturing, who are age 50 and over, and have had diabetes for more than ten years. The investigators will perform 2 transiliac (hip bone) biopsies on each subject, one for mechanical testing, tissue analysis of AGEs, enzymatic crosslinks and bone tissue-bound water in cortical bone, and the other for histomorphometry and high-resolution 3D imaging in trabecular bone. A matched, non-diabetic, healthy control will be enrolled at the time each T1DM is enrolled.

Interventions

  • Procedure Transilial bone biopsy
    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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Compare cortical bone tissue heterogeneity in nanoindentation measures of modulus and hardness between T1DM and controls. [Time frame: 6- 8 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion 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 years post menopausal.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Creighton University Osteoporosis Research Center — Omaha

Identifiers

NCT: NCT05701254 · 1425624-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗