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Hepatic Energy Fluxes in NASH and NAS Patients

NCT03997422 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-08

No results posted yet for this study

Summary

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.

Conditions

  • NASH - Nonalcoholic Steatohepatitis
  • NAS
  • Overweight or Obesity
  • Weight Loss
  • Bariatric Surgery Candidate

Interventions

PROCEDURE

Vertical Sleeve Gastrectomy (VSG)

Vertical Sleeve gastrectomy will be performed using five laparoscopic ports using a 40 French Bougie as a template. If a hiatal hernia is identified it will be repaired. This practice has greatly reduced postoperative reflux disease (see human subjects protection). As VSG for patients with a BMI 30.0-34.9 kg/m2 is not covered by insurance the University hospital will cover costs for up to 24 patients.

Sponsors & Collaborators

Principal Investigators

  • Sayeed Ikramuddin · University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03997422 on ClinicalTrials.gov