Diabetes Reversal and the Subgingival Microbiota

NCT ID: NCT05501093

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2025-06-30

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.

Conditions

Diabetes type2; Bariatric Surgery Candidate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Diabetic patients

Diabetic patients who plan to undergo bariatric surgery

sample collection

Intervention Type: OTHER

Blood, plaque, and other oral samples

Normo-glycemic (non-diabetic) patients

Non-diabetic patients who plan to undergo bariatric surgery

sample collection

Intervention Type: OTHER

Blood, plaque, and other oral samples

Interventions

sample collection

Blood, plaque, and other oral samples

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana Graves, DDS, DMSc

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Temple University

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

1R01DE026603-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

825975

Identifier Type: -

Identifier Source: org_study_id