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NCT03490370: ELVIS
Proof of Concept ELectro-Stimulation of Muscles to resolVe Insulin Resistance in NASH
NA trial testing Electro-muscular stimulation using NeuroTrac MyoPlus 2/4 in NASH - Nonalcoholic Steatohepatitis in 8 participants. Completed in 6 February 2020.
30 November 2018
Quick facts
| Lead sponsor | NHS Tayside |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 3 April 2018 |
| Primary completion | 30 November 2018 |
| Estimated completion | 6 February 2020 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Electro-muscular stimulation using NeuroTrac MyoPlus 2/4
Conditions studied
- NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →
- Insulin Sensitivity — all drugs for Insulin Sensitivity →
Sponsor
NHS Tayside — full company profile →
Who can join
Adults 18 to 75, any sex, with NASH - Nonalcoholic Steatohepatitis or Insulin Sensitivity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03490370
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for NASH - Nonalcoholic Steatohepatitis
Currently open trials in the same condition.
- NCT05499949 — The Franciscus Obesity NASH Study · active not recruiting
- NCT05023044 — Nonalcoholic Fatty Liver Disease in HIV Database · active not recruiting
- NCT04232566 — Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity · recruiting
- NCT05165446 — Novel MRE Technique to Assess a Risk Factor for Liver Cancer · active not recruiting
- NCT04697810 — Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH) · Phase 2 · recruiting
Other NHS Tayside trials
Trials by the same sponsor.
- NCT04099719 — Geographical Information System (GIS) Mapping to Assess the Need for IEP Provision in Tayside · completed
- NCT03649867 — What Have Been the Experiences of Female Survivors of Interpersonal Trauma on the Survive & Thrive Course · NA · completed
- NCT03697135 — Ask a Friend to Take a Test for Hepatitis C Infection · completed
- NCT03513796 — Evaluation of Multiple HCV Diagnosis Pathways for Efficacy, Cost Effectiveness and Cure in NHS Tayside · completed
- NCT03341546 — Estimating Patient Size From a Single Radiograph · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03490370 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NHS Tayside
- Last refreshed: 27 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03490370.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing