Diabetes Reversal and the Subgingival Microbiota
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Diabetic patients Diabetic patients who plan to undergo bariatric surgery |
Other: sample collection
Blood, plaque, and other oral samples
|
| Normo-glycemic (non-diabetic) patients Non-diabetic patients who plan to undergo bariatric surgery |
Other: sample collection
Blood, plaque, and other oral samples
|
Outcome Measures
Primary Outcome Measures
- Bacterial composition [18 months]
The primary outcome variable will be global bacterial composition as determined by 16S rRNA community profiling.
Secondary Outcome Measures
- Bacterial mRNA profiling [18 months]
Bacterial mRNA profiling and gingival crevicular fluid.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women undergoing bariatric surgery who are 25-65 years old.
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BMI > 35 kg/m2.
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Diabetic subjects: HbA1c> 6.75% or fasting plasma glucose >126 mg/dl).
-
Normoglycemic subjects: HbA1c<5.75% or fasting plasma glucose <100 mg/dl).
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Dental criteria: Minimum of 8 posterior teeth.
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Signed and dated informed consent form.
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Willing to comply with all study procedures and be available for the duration of the study.
Exclusion Criteria:
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Subjects diagnosed with type 1 diabetes, maturity onset diabetes of the young (MODY), or latent autoimmune diabetes in adults (LADA).
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Women who are considering pregnancy or are currently breastfeeding.
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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.
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Currently smoke more than 10 cigarettes per day.
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Periodontal treatment within 3 months of bacterial sampling.
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Acute periodontal infection (abscess) within 1 month of bacterial sampling or abscess in teeth or adjacent teeth within 1 month of sampling.
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Treatment with antibiotics within one month of sample collection (except as part of the surgical regimen of prophylactic antibiotic immediately prior to surgery).
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A treatment regimen of steroids within 1 month of sample collection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Temple University | Philadelphia | Pennsylvania | United States | 19104 |
| 2 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
- National Institute of Dental and Craniofacial Research (NIDCR)
- Temple University
- Ohio State University
Investigators
- Principal Investigator: Dana Graves, DDS, DMSc, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 825975
- 1R01DE026603-01A1