Diabetes Reversal and the Subgingival Microbiota | NCT05501093

Studies
Diabetes Reversal and the Subgingival Microbiota

NCT05501093

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Mar 19, 2026Actual

Enrollment

102Actual

Phase

Not provided

Conditions

Diabetes type2
Bariatric Surgery Candidate

Interventions

sample collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01DE026603-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2019Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Jun 30, 2025Actual

First Submitted Date

Aug 12, 2022

First Submission Date that Met QC Criteria

Aug 12, 2022

First Posted Date

Aug 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 19, 2026Actual

Name	Class
National Institute of Dental and Craniofacial Research (NIDCR)	NIH
Temple University	OTHER
Ohio State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
sample collection	Other	Blood, plaque, and other oral samples	Diabetic patients Normo-glycemic (non-diabetic) patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bacterial composition	as determined by 16s rRNA community profiling	18 months

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Facility	Status	City	State	ZIP	Country	Contacts
Temple University		Philadelphia	Pennsylvania	19104	United States
University of Pennsylvania