Diabetes Reversal and the Subgingival Microbiota

University of Pennsylvania

Status

Completed

Conditions

Bariatric Surgery Candidate

Diabetes type2

Treatments

Other: sample collection

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05501093

1R01DE026603-01A1 (U.S. NIH Grant/Contract)

825975

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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.