NCT06519942招募中不适用
Muscle and Bone in Patients With Diabetes Mellitus and Neuropathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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:
- •Fasting glucose > 100 mg/dl
- •HbA1c > 5.7 %
结局指标
主要结局
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.
时间窗: At enrollment
Differences in muscle fiber type distribution, percentage and cross-sectional area will be evaluated through myosin heavy chain (MHC) immunostaining of the muscle specimen.
次要结局
- 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.(At enrollment)
- 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(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(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.(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.(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.(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.(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.(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.(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.(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.(At enrollment)
研究者
研究点 (1)
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