Hepatic Energy Fluxes in NASH and NAS Patients (NCT03997422)
🩺 Plain-English Summary (8th-Grade Level)
Diseases along the nonalcoholic fatty liver disease spectrum, which are tightly coupled to the obesity epidemic, are soon to become the commonest indication for liver transplantation in the United States. Bariatric surgery shows great promise in the treatment of these diseases. The studies proposed herein will be the first to measure in humans the relationships among (i) the liver's ability to burn fat and make glucose, two of its primary functions; (ii) the severity of nonalcoholic fatty liver disease; and (iii) the responses to bariatric surgery. These experiments will support deeper future mechanistic investigations of the metabolic mechanisms underlying nonalcoholic steatohepatitis (NASH) improvement with bariatric surgery. The premise of this study is that deranged hepatic mitochondrial metabolism is a key biomarker and mediator of the nonalcoholic fatty liver disease (NAFLD)/NASH continuum, and the central hypothesis the investigators will test is that preoperative hepatic fat oxidation and glucose production flux parameters differ between low versus high NAFLD activity score (NAS), and response of the liver to bariatric surgery can be predicted by preoperative fluxes.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (27 items).
Location: University of Minnesota — Minneapolis, Minnesota
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
- Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
- Cardiac stress test indicating that surgery or IMM would not be safe.
- Pulmonary embolus or thrombophlebitis in the past six months
- Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
- Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy.
- Serum creatinine \>1.5 mg/dL.
- Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome, or alkaline phosphatase or ALT or AST greater than 2.5 the upper limit of normal. Elevated INR.
- Alcohol intake more than one drink or \>20 grams per day
- History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.
- Gastric or duodenal ulcer in the past six months.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Minnesota — Minneapolis, Minnesota
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.