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Gut bacteria may hold key to better heart health after Weight-Loss surgery

NCT ID NCT05000996

Knowledge-focused Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 300 people who are having weight-loss (metabolic) surgery to see how their gut bacteria change over time and how those changes relate to heart health, diabetes, and cholesterol. Participants provide blood and stool samples before surgery and at several follow-up visits for up to 3 years, with long-term health tracked for up to 10 years. The goal is to learn how gut bacteria might improve surgical outcomes, especially in African Americans who are at higher risk for heart disease.

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.

Participants

About 300 people

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

Started

Aug 2021

Expected to finish

Jan 2035

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.

Who is studied

We plan to enroll 300 patients who undergo metabolic surgery at the Vanderbilt University Medical Center and follow them up to 10 years after surgery

Ages

21 to 65 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: * Be approved and scheduled for metabolic surgery at the Vanderbilt University Medical Center * Have a history of type 2 diabetes, hypertension, or dyslipidemia * Be able and willing to provide personal information and biological samples needed for the study Exclusion Criteria: * Prior gastric operations * A history of coronary artery disease, stroke, heart failure, HIV infection, or untreated viral hepatitis * Chemotherapy or radiotherapy for cancer within 2 years * Current inflammatory bowel disease or celiac disease * Vomiting, constipation, or diarrhea within 7 days or use of antibiotics within 2 months

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Dyslipidemias hyperlipidemia hypertensive disorder inherited lipid metabolism disorder morbid obesity type 2 diabetes mellitus

As listed by the trial registrant

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

Bariatric surgery candidate Cardiovascular diseases Dyslipidemias Hypertension Morbid obesity Type 2 diabetes

How to take part

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

  1. The places running it

    1 site. 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

  • Vanderbilt_University MC

    RECRUITING

    Nashville, Tennessee, 37232, United States

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