Diabetes Reversal and the Subgingival Microbiota

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    234
  • sponsor
    University of Pennsylvania
Updated on 24 October 2022

Summary

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.

Details
Condition Diabetes type2, Bariatric Surgery Candidate
Treatment Sample collection
Clinical Study IdentifierNCT05501093
SponsorUniversity of Pennsylvania
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women undergoing bariatric surgery who are 25-65 years old
BMI > 35 kg/m2
Diabetic subjects: HbA1c> 6.75% or fasting plasma glucose >126 mg/dl)
Normoglycemic subjects: HbA1c<5.75% or fasting plasma glucose <100 mg/dl)
Dental criteria: Minimum of 8 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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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