Diabetes Reversal and the Subgingival Microbiota Study

Brief description of study

The Penn Bariatric and Weight Loss Surgery Program at the University of Pennsylvania

is currently seeking individuals who are planning to undergo bariatric surgery and

willing to undergo an oral examination and provide oral samples at study visits before

and after the surgery. The purpose of this study to determine whether diabetes

alters the subgingival microbial composition and /or bacterial RNA expression by

comparing bacteria obtained from diabetic and nondiabetic individuals.

Detailed description of study

The study objective is to determine whether diabetes alters the oral microbial

composition and /or bacterial RNA expression by comparing bacteria obtained from

diabetic and nondiabetic individuals before and after bariatric surgery.

Eligible participants will be enrolled prior to their bariatric surgery and will attend

5 visits over the course of 18 months.

Participants who qualify for the study and attend all study visits will receive up

to $400. Additionally, after completion of the study participants will receive a

complimentary dental cleaning.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
diabetes,bariatric surgery,weight loss
Age: Between 25 Years - 65 Years
Gender: All

Subject 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.

Subject 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.

Updated on 09 Mar 2024. Study ID: 825975

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