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Proof of Concept ELectro-Stimulation of Muscles to resolVe Insulin Resistance in NASH (ELVIS)

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ClinicalTrials.gov Identifier: NCT03490370
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
John Dillon, NHS Tayside

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Insulin Sensitivity Device: Electro-muscular stimulation using NeuroTrac MyoPlus 2/4 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Proof of concept study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proof of Concept ELectro-Stimulation of Muscles to resolVe Insulin Resistance in NASH (The Elvis Study)
Actual Study Start Date : April 3, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : February 6, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Electronic Muscle Stimulation Activity
Electro-muscular stimulation using NeuroTrac MyoPlus 2/4. All participants taking part will be allocated to the Electronic Muscle Stimulation Activity (EMS) intervention from baseline for the duration of 12 weeks. There will be 6 EMS sessions of 35mins/per session each week.
Device: Electro-muscular stimulation using NeuroTrac MyoPlus 2/4
In this pilot study we aim to determine if change in the muscle metabolism can resolve insulin resistance in NAFLD through muscle stimulation by using electro-stimulation. We hypothesise that 6x35 minute sessions per week over a 12 week time scale would mimic effects of resistance exercise on metabolic parameters associated with NAFLD and hepatic steatosis. All 20 participants will have the electro-stimulation intervention.




Primary Outcome Measures :
  1. Can electro-stimulated muscle activity demonstrate improvement in insulin resistance. [ Time Frame: 10 months ]
    Change from baseline of frequent sampled Oral Glucose Tolerance Testing (fsOGTT) to end of treatment


Secondary Outcome Measures :
  1. Can electro-stimulated muscle activity demonstrate improvement in hepatic steatosis [ Time Frame: 10 months ]
    Change from baseline of liver steatosis to end of treatment via Magnetic Resonance



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490370


Locations
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United Kingdom
NHS Tayside
Dundee, United Kingdom
Sponsors and Collaborators
NHS Tayside
Investigators
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Principal Investigator: John Dillon, MD NHS Tayside

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Responsible Party: John Dillon, Professor, NHS Tayside
ClinicalTrials.gov Identifier: NCT03490370    
Other Study ID Numbers: 2017GA07
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs