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Sleeve gastrectomy vs. lifestyle: which tames fatty liver disease?

NCT ID NCT03587831

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two approaches for treating non-alcoholic steatohepatitis (NASH), a serious liver condition linked to obesity. Half of the 48 participants will receive vertical sleeve gastrectomy surgery along with lifestyle counseling, while the other half will get lifestyle counseling alone. Researchers will measure liver health after 12 months to see which group improves more.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vertical sleeve gastrectomy surgery and lifestyle modification counseling
What this could lead to
If successful, this could show that adding weight-loss surgery to lifestyle changes is a safe and effective way to reduce liver damage in NASH patients.
What could go wrong
This is a small pilot study with only 48 people, so results may not apply to everyone. Surgery also carries risks like infection or complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 30 to 70 years at eligibility visit. * At least one of the following: * Diagnosed with NASH with a total NAS ≥ 4 including a ballooning score of at least 1 * Diagnosed with T2DM or prediabetes, HbA1c\< 9% * Body Mass Index (BMI): 35.0-60.0 kg/m2 at eligibility visit. * Willingness to accept random assignment to either treatment group. * All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all participants enrolled in the study * Evidence of liver fat present in the baseline MR images * Suitable for liver biopsy * Willingness to comply with the follow-up protocol and successful completion of the run-in (described below). * Written informed consent. * English speaking 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. * 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 2.0 g/dL or more below normal range) or history of coagulopathy. (Low range for women would be 10, low range for men would be 11) * Serum creatinine \>1.8 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 2.5x 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. * History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment). * Previous organ transplantation. * Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease. * Currently pregnant or nursing, or planning to become pregnant in the next two years. * History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years. * Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol. * A score of 17 or greater on the CES-D questionnaire administered on a typical week for the participant. * Presence of any chronic or debilitating disease that would make adherence to the protocol difficult. * Serum c-peptide \<1.0 ng/ml post prandial. * Exclusions may also be made at the discretion of the attending physician or the eligibility committee. * History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus. * Any history of dysphagia. * Fibrosis score \> 3 * Use of Rezdiffra (resmetirom).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Minneapolis VA Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55417, United States

  • Pennington Biomedical Research Center

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of San Fransisco

    RECRUITING

    San Francisco, California, 94143, United States

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