COMPLETED

Diabetes Reversal and the Subgingival Microbiota

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Diabetes Reversal and the Subgingival Microbiota

Quick Facts

Study Start:2019-03-11
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05501093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women undergoing bariatric surgery who are 25-65 years old.
  2. * BMI \> 35 kg/m2.
  3. * Diabetic subjects: HbA1c\> 6.0% or fasting plasma glucose \>126 mg/dl).
  4. * Normoglycemic subjects: HbA1c\<5.75% or fasting plasma glucose \<100 mg/dl).
  5. * Dental criteria: Minimum of 4 posterior teeth.
  6. * Signed and dated informed consent form.
  7. * Willing to comply with all study procedures and be available for the duration of the study.
  1. * Subjects diagnosed with type 1 diabetes, maturity onset diabetes of the young (MODY), or latent autoimmune diabetes in adults (LADA).
  2. * Women who are considering pregnancy or are currently breastfeeding.
  3. * 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.
  4. * Currently smoke more than 10 cigarettes per day.
  5. * Periodontal treatment within 3 months of bacterial sampling.
  6. * Acute periodontal infection (abscess) within 1 month of bacterial sampling or abscess in teeth or adjacent teeth within 1 month of sampling.
  7. * Treatment with antibiotics within one month of sample collection (except as part of the surgical regimen of prophylactic antibiotic immediately prior to surgery).
  8. * A treatment regimen of steroids within 1 month of sample collection.

Contacts and Locations

Principal Investigator

Dana Graves, DDS, DMSc
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Temple University
Philadelphia, Pennsylvania, 19104
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Dana Graves, DDS, DMSc, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-11
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2019-03-11
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes type2
  • Bariatric Surgery Candidate