Идёт набор NCT06519942

Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy

— Наблюдательное Diabetes Mellitus, Type 2 Diabetic Peripheral Neuropathy Sarcopenia

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: Blood sampling, Electromyoneurography (EMNG), Muscle biopsy, Quantitative peripheral computed tomography (qPCT).
Кому может быть актуально: Состояния в реестре: Diabetes Mellitus, Type 2, Diabetic Peripheral Neuropathy, Sarcopenia. Базовые параметры: 40 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this observational study is to evaluate muscle fiber type composition in people with type 2 diabetes mellitus (T2DM) with a common complication of T2DM: diabetic peripheral neuropathy (DNP), specifically diabetic sensorimotor polyneuropathy. Researchers will also look into factors related to DNP: inflammation, the use of energy in the cell, nerve function and the tiny blood vessels in the muscle. The main question it aims to answer is: Are there differences in muscle fiber type composition between persons with T2DM with and without DNP, in comparison to sex and age-matched healthy peers? Participants will partake in the following tests: * electromyoneurography (EMNG): evaluation of nerve function, damage and repair; for diagnosis of DNP or other diseases of the nerves * blood analysis: researchers will measure insulin, blood sugar, lipid profile, inflammation * muscle biopsy in the calf (m. gastrocnemius): a doctor will take a small sample of muscle to evaluate the muscle shape and structure * mechanography: patients will perform functional tests (e.g. standing up from a chair), researchers will evaluate maximal power and maximal force of the muscles by jumping tests * questionnaires: on food intake, physical activity, smoking history, alcohol use, medical history * measurement of height, weight, and the comparison of the hip and waist circumference * peripheral Quantitative Computed Tomography (pQCT): scan of the calf for muscle density and bone density * electrocardiography (ECG): evaluation of electrical signals of the heart Researchers will compare (1) patients with T2DM with DNP, (2) patients with T2DM without DNP, and (3) healthy persons to see if there are differences in muscle fiber type composition

Вмешательства

Диагностический тест Blood sampling
Fasting blood samples will be obtained.
Диагностический тест Electromyoneurography (EMNG)
Nerve conduction of sensory and motor nerves of the upper and lower limb will be performed, including F- and H-waves. Needle EMNG of the m. tibialis anterior, m. gastrocnemius (medial head), m. tensor fascia lata and m. gluteus maximus) will be performed.
Процедура Muscle biopsy
Muscle biopsy of the m. gastrocnemius will be performed under local anesthesia using the modified Bergström technique.
Лучевая терапия Quantitative peripheral computed tomography (qPCT)
A qPCT scan of the calf will be performed.
Устройство Mechanography
Single two leg jump, multiple one leg hopping, chair rise and sit to stand tests will be performed.
Диагностический тест Electrocardiography (ECG)
A 15-minute resting ECG will be performed.
Другое Questionnaires
Questionnaires will be performed to collect information on medical background (drug use, comorbidities, symptoms of peripheral neuropathy, ...) and lifestyle factors (ethyl consumption, food intake, physical activity, smoking).
Другое Anthropometry
Length and hip:waist ratio will be measured. Furthermore, body weight and composition will be determined by bio-impedance measurement. Systolic and diastolic blood pressure (mean of 3 times) will be evaluated.

Первичные конечные точки

Differences in muscle fiber type composition in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. [Срок оценки: At enrollment]

Вторичные конечные точки (11)

Differences in nerve conduction velocity in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls [Срок оценки: At enrollment]
Differences in capillarization in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. [Срок оценки: At enrollment]
Differences in electron microscopic properties assessing mitochondrial function in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls [Срок оценки: At enrollment]
Differences in maximal force in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. [Срок оценки: At enrollment]
Differences in maximal power in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. [Срок оценки: At enrollment]
Differences in functional muscle strength in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. [Срок оценки: At enrollment]
Differences in physical activity levels in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. [Срок оценки: At enrollment]
Differences in food intake in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. [Срок оценки: At enrollment]
Differences in lifestyle factors in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. [Срок оценки: At enrollment]
Differences in muscle density in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. [Срок оценки: At enrollment]
Differences in bone density in persons with type 2 diabetes with diabetic peripheral neuropathy compared to persons with type 2 diabetes without diabetic neuropathy and healthy controls. [Срок оценки: At enrollment]

Критерии участия

Критерии включения

All participants:

Between 40-70 years of age
BMI between 18,5 - 35 kg/m2

Persons with T2DM:

More than 10-year clinical diagnosis of T2DM

Критерии исключения

All participants:

Possible other causes of nerve impairment (vitamin B12 deficiency, excessive alcohol consumption, chemotherapy)
Immobilisation (1) > 3 months in past history or (2) > 4 weeks in past 6 months
Chronic conditions affecting the vital organs (New York Heart Association (NYHA) 3/4, Global Initiative for Obstructive Lung Disease (GOLD) 3/4, cystic fibrosis)
Hypogonadism
Inflammatory joint or intestinal diseases
Chronic muscle diseases
Active malignancy
Malnutrition disease, eating disorder or bariatric surgery
Medication use (anticoagulants, glucocorticoids, anti-androgen or anti-estrogen treatment) persons with T2DM:
Insufficient control of diabetes (HbA1c >9%)

Healthy controls: