Proof of Concept ELectro-Stimulation of Muscles to resolVe Insulin Resistance in NASH (The Elvis Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Tayside
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Can electro-stimulated muscle activity demonstrate improvement in insulin resistance.
研究概览
简要总结
Non-alcoholic steato-hepatitis (NASH) affects up to 3% of the population and leads to liver cirrhosis, hepatocellular carcinoma (HCC) and death. The only known treatment is weight loss and exercise. Many patients cannot or will not achieve this with conventional means. The pathogenic process of the disease is insulin resistance which can be reversed relatively quickly with intense exercise or electrical stimulation of muscle. Most patients cannot achieve or sustain the level of aerobic exercise required; resistance exercise is more sustainable and similarly effective. The aim of this pilot study is to investigate whether electro-muscle stimulation, designed to emulate resistance exercise, resolves NASH in patients and moves them to a less dangerous metabolic steady state which should be easier to maintain.
详细描述
This is a pilot study which will determine if muscle stimulation by using electro-stimulation can mimic resistance exercise and improve insulin resistance and hepatitis steatosis. We aim to recruit up to 20 patients into the study, needing a minimum of 12 subjects suitable for per protocol analysis. The participants will self-administer EMS for 8 -12 weeks. An interim analysis of change in insulin resistance at 8 weeks of study will be undertaken in the first 4 patients, if this shows a clear effect the study period will be shortened to 8 weeks.
Patients with biopsy proven NASH will be approached by their clinician at their routine liver outpatient clinic and provided with study information alongside the contact details of study staff. Patients will be given adequate time (over 24 hours) to consider the study and will be asked to contact research staff by email or telephone supplied on the PIS if they then wish to participate in the study or require further information. An appointment will be arranged to attend for study screening convenient to the patient where a full in-depth discussion will take place prior to consent or any study procedures undertaken.
Study participants will then follow the study pathway as shown in the flow chart, (section 3.2) Study Matrix (3.3) and as described in the study assessments schedule (section 6).
Electro Muscle Stimulation (EMS) will commence at baseline visit, which will take place in the Institute of Motion Analysis & Research centre, Ninewells hospital, 6 sessions per week self-administered at home, of up to 35 minutes duration for up to a total of 12 weeks. Participants will self-administer muscle stimulation via the Neurotrac Myoplus 2/4 device. Manufactured by: Verity Medical Ltd, in compliance with the European Union Medical Device Directive MDD93/42/EEC under the supervision of SGS, Notified Body number 0120. CE 0120.
Custom STIM (stimulation) mode settings will be utilised and locked for safety. Each participant's own tolerance for the settings within regulated parameters will be used to ensure patient comfort but also allow for optimum muscle activity. 4 channels on the device will be used with 2 sets of skin electrodes attached to the medial and lateral aspects of the quadriceps muscles of each leg.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/ Female aged 18 - 75
- •Able to give informed consent
- •Biopsy proven NASH with a NAS (NAFLD activity score) activity score equal to or greater than 3
- •A single hepatic diagnosis.
排除标准
- •Presence of other causes of Chronic Liver Disease
- •Currently or previously decompensated liver disease (ascites, encephalopathy or variceal bleeding)
- •Hepatocellular carcinoma (current or previous)
- •Malignancy - of any sort except basal cell carcinoma
- •Unstable co morbid disease
- •Known HIV positive
- •Limb amputation
- •Implanted electrical device
- •Pregnancy, breastfeeding or undertaking fertility treatment
- •Type 1 Diabetes Mellitus (Type 2 diabetes mellitus, diet and metformin acceptable for inclusion)
- •Alcohol intake above 14 units a week
- •Unable to give informed consent
- •Unable to attend required study visits.
结局指标
主要结局
Can electro-stimulated muscle activity demonstrate improvement in insulin resistance.
时间窗: 10 months
Change from baseline of frequent sampled Oral Glucose Tolerance Testing (fsOGTT) to end of treatment
次要结局
- Can electro-stimulated muscle activity demonstrate improvement in hepatic steatosis(10 months)