Insulin Sensitivity Clinical Trial
— ELVISOfficial title:
Proof of Concept ELectro-Stimulation of Muscles to resolVe Insulin Resistance in NASH (The Elvis Study)
NCT number | NCT03490370 |
Other study ID # | 2017GA07 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 3, 2018 |
Est. completion date | February 6, 2020 |
Verified date | February 2020 |
Source | NHS Tayside |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | February 6, 2020 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Tayside | Dundee |
Lead Sponsor | Collaborator |
---|---|
NHS Tayside |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Can electro-stimulated muscle activity demonstrate improvement in hepatic steatosis | Change from baseline of liver steatosis to end of treatment via Magnetic Resonance | 10 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03458741 -
How is Glycogen Supercompensation Regulated in Human Skeletal Muscle
|
N/A | |
Recruiting |
NCT06042517 -
Mechanisms of Ultrasound Neuromodulation Effects in Diabetes
|
N/A | |
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Completed |
NCT03689738 -
Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety
|
N/A | |
Recruiting |
NCT04195165 -
The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test
|
N/A | |
Recruiting |
NCT05441982 -
Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes
|
N/A | |
Terminated |
NCT03325933 -
Resistance Training and Cardiometabolic Health
|
N/A | |
Recruiting |
NCT05791968 -
Blood Donation Could Improve Insulin Sensitivity
|
N/A | |
Suspended |
NCT03240978 -
Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese
|
N/A | |
Completed |
NCT02913079 -
The Acute Impact of Sit-stand Desks on Post-meal Blood Sugar Levels
|
N/A | |
Completed |
NCT02700698 -
Mitochondrial Function in Circulating Cells and Muscle Tissue
|
||
Recruiting |
NCT01972113 -
Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
|
N/A | |
Completed |
NCT02058914 -
Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents
|
N/A | |
Enrolling by invitation |
NCT02192684 -
Obesity, Sleep Apnea, and Insulin Resistance
|
N/A | |
Completed |
NCT00936130 -
Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity
|
N/A | |
Completed |
NCT01216956 -
Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia
|
N/A | |
Recruiting |
NCT05992688 -
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
|
N/A | |
Recruiting |
NCT04168372 -
Fructose: Substrate, Stimulus, or Both?
|
N/A | |
Recruiting |
NCT05443347 -
Activity, Adiposity, and Appetite in Adolescents 2 Intervention
|
N/A | |
Terminated |
NCT04239482 -
Nutritional Supplementation and Insulin Sensitivity
|
N/A |