Examining the effects of bariatric surgery on oral bacteria in diabetic and non-diabetic patients
Diabetes Reversal and the Subgingival Microbiota
This study is testing how bariatric surgery affects the bacteria in the mouths of people with and without type 2 diabetes to see if it impacts their oral health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 234 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT05501093 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how bariatric surgery influences the subgingival microbiota in individuals with type 2 diabetes compared to those without diabetes. Participants, aged 25-65 with a BMI over 35, will undergo screening and baseline assessments before surgery, followed by three follow-up visits to collect blood and oral samples at specified intervals. The study aims to understand the relationship between diabetes and oral bacterial changes, which may have implications for oral health. An optional dental cleaning will be offered at the final visit.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 25-65 who are undergoing bariatric surgery and meet specific diabetes and dental health criteria.
Not a fit: Patients with type 1 diabetes, certain autoimmune diseases, or those currently smoking more than 10 cigarettes per day may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the relationship between diabetes and oral health, potentially leading to improved management strategies for diabetic patients.
How similar studies have performed: While the specific focus on oral bacteria in relation to bariatric surgery and diabetes is novel, related studies have shown that changes in microbiota can impact health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- Temple University — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Dana Graves, DDS, DMSc — University of Pennsylvania
- Study coordinator: Renee Tangi
- Email: pdm-bariatricsurgery@upenn.edu
- Phone: 215-888-4045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.