RECRUITINGOBSERVATIONAL

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

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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) \&gt;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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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) \&gt;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.

Treatments Being Tested

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.

Locations (1)

Creighton University Osteoporosis Research Center

Omaha, Nebraska, United States