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

NCT03490370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-02-27

No results posted yet for this study

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.

Conditions

  • NASH - Nonalcoholic Steatohepatitis
  • Insulin Sensitivity

Interventions

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.

Sponsors & Collaborators

  • NHS Tayside

    lead OTHER_GOV

Principal Investigators

  • John Dillon, MD · NHS Tayside

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2018-11-30
Completion
2020-02-06

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03490370 on ClinicalTrials.gov