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Gut check for gums: Surgery's surprising effect on mouth bugs

NCT ID NCT05501093

Knowledge-focused Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how bariatric surgery changes the bacteria in the mouths of people with and without type 2 diabetes. Researchers collected blood and plaque samples before and after surgery from 102 participants. The goal was to understand if diabetes alters mouth bacteria in ways that could affect oral health.

What this could mean

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

What this could lead to
If successful, this could reveal how diabetes-related changes in mouth bacteria affect oral health, pointing to new ways to prevent dental problems in people with diabetes.
What could go wrong
This is an observational study, not a treatment trial. It only looks at bacteria changes after surgery, so it cannot prove cause and effect or lead directly to a new therapy.

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

102 people

The number who actually took part.

Started

Mar 2019

Finished

Jun 2025

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

The study participants will be men and women, 25-65 years old, with a Body Mass Index (BMI) of ≥35 kg/m2 who are scheduled to undergo bariatric surgery at the University of Pennsylvania or Temple University for treatment of obesity or obesity and type 2 diabetes. The total target enrollment is 130 diabetic and 104 normoglycemic subjects.

Ages

25 to 65 years

Sex

Anyone

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: * Men and women undergoing bariatric surgery who are 25-65 years old. * BMI \> 35 kg/m2. * Diabetic subjects: HbA1c\> 6.0% or fasting plasma glucose \>126 mg/dl). * Normoglycemic subjects: HbA1c\<5.75% or fasting plasma glucose \<100 mg/dl). * Dental criteria: Minimum of 4 posterior teeth. * Signed and dated informed consent form. * Willing to comply with all study procedures and be available for the duration of the study. Exclusion Criteria: * Subjects diagnosed with type 1 diabetes, maturity onset diabetes of the young (MODY), or latent autoimmune diabetes in adults (LADA). * Women who are considering pregnancy or are currently breastfeeding. * Individuals with a history of chronic inflammatory or autoimmune diseases or taking medications that affect immune function or affect body weight such as chronic systemic steroids. * Currently smoke more than 10 cigarettes per day. * Periodontal treatment within 3 months of bacterial sampling. * Acute periodontal infection (abscess) within 1 month of bacterial sampling or abscess in teeth or adjacent teeth within 1 month of sampling. * Treatment with antibiotics within one month of sample collection (except as part of the surgical regimen of prophylactic antibiotic immediately prior to surgery). * A treatment regimen of steroids within 1 month of sample collection.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Bariatric surgery candidate Diabetes TYPE2

Contacts and locations

Locations

  • Temple University

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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