Insulin Resistance Clinical Trial
— ECLIPSEOfficial title:
Effect of Carnitine Supplementation on Liver Steatosis, Insulin Sensitivity, Plasma Glucose Homeostasis, Skeletal Muscle Metabolism and Energetics: a Pilot Study
Verified date | November 2021 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It will be evaluated whether carnitine, a dietary supplement, reduces liver fat and improves metabolism in individuals who have a high concentration of fat within their liver. Participants will be given either Carnitine or placebo, together with a meal replacement milkshake twice daily for 6 months.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 1, 2021 |
Est. primary completion date | August 30, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Elevated liver fat on screening abdominal ultrasound - Capable of providing informed consent - Non-vegetarian diet - BMI <40 kg/m2 - Weekly ethanol consumption <21 units/week - Negative non-invasive liver screen, including Hepatitis B and C serology, liver autoantibodies, transferrin saturation, a1-antitrypsin levels. Exclusion Criteria: - Known history of cardiovascular disease - Known diabetes mellitus - Known psychiatric comorbidity - Chronic kidney disease - Surgery within 6 months prior to start of study - Exposure to drugs known to influence hepatic steatosis (including steroids, statins, omega-3-fatty acids) - Current smokers - Contraindications to magnetic resonance scanning, including implanted ferrous material (implantable pacemakers or defibrillators), metallic ocular foreign bodies, ferromagnetic aneurysm clips or severe claustrophobia. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | David Greenfield Human Physiology Unit | Nottingham | Notts |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | National Institute for Health Research, United Kingdom, Nottingham University Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intrahepatic triglyceride (IHTG) content | IHTG measured by proton magnetic resonance spectroscopy | 24 weeks | |
Secondary | liver sensitivity to insulin | suppression of glucose output from the liver during a 20 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp | 24 weeks | |
Secondary | whole body insulin sensitivity | whole body glucose uptake during a 50 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp | 24 weeks | |
Secondary | Muscle lipid content | lipid content of the vastus lateralis muscle measured by proton magnetic resonance spectroscopy | 24 weeks | |
Secondary | Skeletal muscle sensitivity to insulin | Arterialised-venous vs. femoral venous difference in blood glucose concentration during the last hour of a 2 hour 50 mU.m-2.min-1 hyperinsulinaemic euglycaemic clamp | 24 weeks | |
Secondary | whole body composition | Fat and lean tissue mass assessment by dual energy X-ray absorptiometry | 24 weeks | |
Secondary | Liver energy metabolism | hepatic ATP flux assessed by 31-phosphorous magnetic resonance spectroscopy | 24 weeks |
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