Reversing Diabetic Peripheral Neuropathy Through Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Glycosylated Hemoglobin (HbA1c)
研究概览
简要总结
This project proposes a longitudinal design that uses multinuclear-MRI to evaluate the mechanistic effects of exercise on skeletal muscle function and peripheral nerve integrity in patients with diabetic peripheral neuropathy (DPN), and to determine whether exercise can reverse DPN symptoms. The investigators will prescribe a 10-week exercise program to 40 DPN patients. The investigators will acquire multinuclear-MRI data before and after the intervention that can provide mechanistic insight into the adaptations in lower leg muscle function and peripheral nerve integrity of patients with DPN, and their role in improving DPN symptoms following physical exercise intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Be between the ages of 40 and 70
- •Clinical diagnosis of Type 2 diabetes
- •Clinical diagnosis of DPN
- •Have a BMI less than 40 kg/m2 (due to magnet bore restrictions)
- •Able to walk unassisted
排除标准
- •Serious cardiac pathology or musculoskeletal problems that would limit exercise ability
- •MNSI score < 1
- •Current open wound or history of plantar ulcer for the last 3 months
- •Partial foot amputations
- •Inability to ambulate without assistive device
- •Stroke or other central nervous system pathology
- •Stage 2 hypertension (resting blood pressure >160 systolic or >100 diastolic)
- •Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems).
- •Subjects with alcoholism, chronic drug use, chronic gastrointestinal disease, or renal or hepatic impairment
- •Pregnant women and children
结局指标
主要结局
Glycosylated Hemoglobin (HbA1c)
时间窗: Week 10
The glycosylated hemoglobin test shows what a person's average blood glucose level was for the 2 to 3 months before the test. Measured via patient blood samples.
Change From Baseline in Body Mass Index (BMI)
时间窗: Week 10
The BMI calculation divides an adult's weight in kilograms by their height in meters squared.
C-Reactive Protein Levels
时间窗: Week 10
Measured via patient blood samples.
MNSI Physical Exam Score
时间窗: Week 10
Completed by physician. Assessment of abnormalities in the appearance of the feet, vibration sense, reflexes, and monofilament sensation. The total score ranges from 0-10; lower scores indicate greater physical health; a decrease in scores indicates physical health increased during the observational period.
Intramuscular Adipose Tissue (IMAT) Levels in the Gastrocnemius Muscle Groups
时间窗: Week 10
Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the gastrocnemius muscle groups of both calf muscles combined.
IMAT Levels in the Soleus Muscle Groups
时间窗: Week 10
Measured using IDEAL-MRI. IMAT levels are quantified as a percentage of total tissue in the soleus muscle groups of both calf muscles combined.
Fractional Anisotropy (FA) in the Tibial Nerve
时间窗: Week 10
FA is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. Measured using Diffusion Tensor Imaging (DTI).
Apparent Diffusion Coefficient (ADC) in the Tibial Nerve
时间窗: Week 10
ADC is a measure of the magnitude of diffusion (of water molecules) within tissue. Measured using DTI.
Body Mass Index (BMI)
时间窗: Baseline
The BMI calculation divides an adult's weight in kilograms by their height in meters squared.
Michigan Neuropathy Screening Instrument (MNSI) Symptom Questionnaire
时间窗: Week 10
15-question assessment of symptoms. Responses of "yes" to items 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. A "no" response on items 7 and 13 counts as 1 point. Item 4 is a measure of impaired circulation and item 10 is a measure of general asthenia; neither are included in scoring. The total score ranges from 0-13; lower scores indicate less prevalent symptoms; a decrease in scores indicates symptoms decreased during the observational period.
Calf Muscle Performance
时间窗: Week 10
Performance will be quantified as peak ankle plantarflexion torque at 60 degrees/sec.
PCr Resynthesis Rate in the Gastrocnemius Muscle Groups
时间窗: Week 10
Measured using multinuclear-MRI following a 90-second plantar flexion exercise during which resistance is applied at approximately 40% of the individual's maximum voluntary contraction. The value reported in the data table represents the average flexion across both calf muscles.
Physical Performance Test (PP) Score
时间窗: Week 10
9-item assessment of Physical Performance. The total score ranges from 0 to 36; higher scores indicate greater levels of physical performance.
次要结局
未报告次要终点