Skip to main content
OpenTrials
Completed

NCT Number: NCT05501093

Diabetes Reversal and the Subgingival Microbiota

This study seeks to examine the impact of bariatric surgery on oral bacteria in diabetic compared to non-diabetic patients. The purpose of this research study is to examine how diabetes changes the bacteria in the mouth. This is an important question since bacterial changes may impact oral health. Participants will attend a screening and baseline visit prior to bariatric surgery and three post bariatric surgery appointments (3 weeks post, 6 months post and 1 year to 18 months post). Samples collected at each study visit include blood, plaque, and other oral samples. At the last study visit there is an optional dental cleaning.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes type2 Bariatric Surgery Candidate

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Temple University, Philadelphia, Pennsylvania, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sample collection

Other

Blood, plaque, and other oral samples

Primary outcomes

  1. Bacterial composition

    Time frame: 18 months

    as determined by 16s rRNA community profiling

Secondary outcomes

  1. Bacterial mRNA profiling

    Time frame: 18 months

    RNA will be isolated then amplified by the MessageAmp II bacterial RNA amplification kit (Ambion/Life Technologies). Ribosomal RNA will be depleted with the RiboZero human/mouse and meta bacterial kits (Epicentre/Illumina) and human mRNA will be depleted with oligo(dT). Illumina sequencing libraries will be constructed with the Illumina TruSeq RNA kit and assessed with an Illumina HiSeq instrument.

  2. Gingival inflammation

    Time frame: 18 mos.

    samples will be assessed for inflammatory cytokines (e.g. IL-1β, IL-17 or TNF) by multiplex assay or ELISA assay

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)
  • Ohio State University
  • Temple University

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.