Clinical trial NCT05501093: Diabetes Reversal and the Subgingival Microbiota
Official title: Diabetes Reversal and the Subgingival Microbiota
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes type2
Bariatric Surgery Candidate
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: Temple University
name: Ohio State University
First posted: 2022-08-15
Enrollment: 234
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study participants will be men and women, 25-65 years old, with a Body Mass Index (BMI) of ≥35 kg/m2 who are scheduled to undergo bariatric surgery at the University of Pennsylvania or Temple University for treatment of obesity or obesity and type 2 diabetes. The total target enrollment is 130 diabetic and 104 normoglycemic subjects.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Bacterial composition
timeFrame: 18 months
Secondary outcomes:
measure: Bacterial mRNA profiling
timeFrame: 18 months
measure: Gingival inflammation
timeFrame: 18 mos.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Dana Graves, DDS, DMSc
role: PRINCIPAL_INVESTIGATOR
References: