Diabetes Reversal and the Subgingival Microbiota

Bariatric Surgery Candidate Clinical Trial

Official title:

Diabetes Reversal and the Subgingival Microbiota

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501093
• Other study ID #: 825975
• Secondary ID: 1R01DE026603-01A
• Status: Recruiting
• Start date: March 11, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Renee Tangi
• Phone: 215-888-4045
• Email: pdm-bariatricsurgery[@]upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes type2

Intervention

Other:
• sample collection
Blood, plaque, and other oral samples

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Dental and Craniofacial Research (NIDCR), Ohio State University, Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial composition	as determined by 16s rRNA community profiling	18 months
Secondary	Bacterial mRNA profiling	RNA will be isolated then amplified by the MessageAmp II bacterial RNA amplification kit (Ambion/Life Technologies). Ribosomal RNA will be depleted with the RiboZero human/mouse and meta bacterial kits (Epicentre/Illumina) and human mRNA will be depleted with oligo(dT). Illumina sequencing libraries will be constructed with the Illumina TruSeq RNA kit and assessed with an Illumina HiSeq instrument.	18 months
Secondary	Gingival inflammation	samples will be assessed for inflammatory cytokines (e.g. IL-1ß, IL-17 or TNF) by multiplex assay or ELISA assay	18 mos.