Diabetes Reversal and the Subgingival Microbiota

NCT05501093 | Completed

• 2 other identifiers: 8259751R01DE026603-01A1
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Bacterial composition

  as determined by 16s rRNA community profiling

  18 months

Secondary Outcomes (2)

• Bacterial mRNA profiling

  18 months

• Gingival inflammation

  18 mos.

Study Arms (2)

Diabetic patients

Diabetic patients who plan to undergo bariatric surgery

Other: sample collection

Normo-glycemic (non-diabetic) patients

Non-diabetic patients who plan to undergo bariatric surgery

Other: sample collection

Interventions

sample collection OTHER

Blood, plaque, and other oral samples

Diabetic patients; Normo-glycemic (non-diabetic) patients

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: collaborator
• Ohio State University: collaborator
• University of Pennsylvania: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (2)

Temple University

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Oral plaque was collected with the use of a microbrush, small paper points and periopaper strips.

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Dana Graves, DDS, DMSc

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 15, 2022
• Study Start: March 11, 2019
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (2)