Diabetes type2NCT05501093
Diabetes Reversal and the Subgingival Microbiota
An observational study of Diabetes type2 and Bariatric Surgery Candidate, run by University of Pennsylvania at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Diabetes type2, Bariatric Surgery Candidate
- What is being tested?
- sample collection
- Type of treatment
- Pill or oral medicine
- How many people
- 102 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Mar 2019to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Temple University
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
- Being tested
- sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sample collectionOther
Blood, plaque, and other oral samples
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Diabetic patients who plan to undergo bariatric surgery Receives: Other: sample collection | |
| Normo-glycemic (non-diabetic) patients | Non-diabetic patients who plan to undergo bariatric surgery Receives: Other: sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial composition
as determined by 16s rRNA community profiling
Measured: 18 months
Secondary outcomes (2)
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.
Measured: 18 months
Gingival inflammation
samples will be assessed for inflammatory cytokines (e.g. IL-1β, IL-17 or TNF) by multiplex assay or ELISA assay
Measured: 18 mos.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start11 Mar 2019
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type2Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Temple University, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Dana Graves, DDS, DMSc, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501093
- Sponsor's protocol ID
- 825975
- Other IDs
- 1R01DE026603-01A1
- Status last verified
- Mar 2026
- First submitted
- 12 Aug 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Reversal and the Subgingival Microbiota
- ClinicalTrials.gov ID
- NCT05501093
- Acronym / sponsor ID
- 825975
- Conditions
- Diabetes type2, Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Temple University, Ohio State University
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Other: sample collectionDiabetic patients who plan to undergo bariatric surgery |
| Normo-glycemic (non-diabetic) patients | – | Other: sample collectionNon-diabetic patients who plan to undergo bariatric surgery |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sample collectionBlood, plaque, and other oral samples | Other | Diabetic patients, Normo-glycemic (non-diabetic) patients |
Primary outcome
Bacterial composition
Time frame: 18 months
as determined by 16s rRNA community profiling
2 secondary outcomes
Bacterial mRNA profiling
Time frame: 18 months
Gingival inflammation
Time frame: 18 mos.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Graves, DDS, DMSc principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes type2 and Bariatric Surgery Candidate, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial composition (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.