Идёт набор NCT05701254

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

— Наблюдательное Type 1 Diabetes Osteopenia Bone Loss Fractures, Bone

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Transilial bone biopsy.
Кому может быть актуально: Состояния в реестре: Type 1 Diabetes, Osteopenia, Bone Loss, Fractures, Bone. Базовые параметры: от 50 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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

Подробное описание

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.

Вмешательства

Процедура 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.

Первичные конечные точки

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

Вторичные конечные точки (1)

Compare cortical bone tissue heterogeneity in nanoindentation measures of modulus and hardness between T1DM and controls. [Срок оценки: 6- 8 weeks]

Критерии участия

Критерии включения

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) \&gt;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