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

NCT03490370 | Completed

• 1 other identifier: 2017GA07
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

NASH - Nonalcoholic Steatohepatitis; Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Can electro-stimulated muscle activity demonstrate improvement in insulin resistance.

  Change from baseline of frequent sampled Oral Glucose Tolerance Testing (fsOGTT) to end of treatment

  10 months

Secondary Outcomes (1)

• Can electro-stimulated muscle activity demonstrate improvement in hepatic steatosis

  10 months

Study Arms (1)

Electronic Muscle Stimulation Activity

EXPERIMENTAL

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

Interventions

Electro-muscular stimulation using NeuroTrac MyoPlus 2/4 DEVICE

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.

Electronic Muscle Stimulation Activity

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Alcohol intake above 14 units a week
• Unable to give informed consent
• Unable to attend required study visits.

Sponsors & Collaborators

• NHS Tayside: lead

Study Sites (1)

NHS Tayside

Dundee, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Insulin Resistance

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• John Dillon, MD

  NHS Tayside

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Proof of concept study.

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 6, 2018
• Study Start: April 3, 2018
• Primary Completion: November 30, 2018
• Study Completion: February 6, 2020
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)