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

NCT ID: NCT05701254

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-18
• Study Completion Date: 2025-01-31

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

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.

Conditions

Type 1 Diabetes; Osteopenia; Bone Loss; Fractures, Bone

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Transilial bone biopsy

Intervention Type: 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.

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.

Transilial bone biopsy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammed Akhter, PhD

Role: PRINCIPAL_INVESTIGATOR

Creighton University Osteoporosis Research Center

Locations

Creighton University Osteoporosis Research Center

Omaha, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Adam Hornig

Role: CONTACT

adam.hornig@unmc.edu

402-559-9116

Laura Armas, M.D.

Role: CONTACT

laura.armas@unmc.edu

402-559-8700

Facility Contacts

Adam Hornig

Role: primary

adam.hornig@unmc.edu

402-559-9116

Mohammed Akhter, PhD

Role: backup

mohammedakhter@creighton.edu

402-280-5019

Other Identifiers

1425624-3

Identifier Type: -

Identifier Source: org_study_id