Periodontal DiseaseNCT06582056
Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age
A study testing Investigational Procedure in people with Periodontal Disease, run by Sanofi Pasteur, a Sanofi Company at 4 sites in United States.
Trial summary
The purpose of this study is to learn about the interactions of markers of type 2 diabetes (T2DM) and periodontitis (PD). Study VPE00001 is a multi-center cross-sectional study. Participants will be categorized based on point-of-care hemoglobin A1c (HbA1c) and periodontal disease (PD) staging into 9 subgroups. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Investigational Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Oct 2024to 30 Sep 2025
- Phase
- Interventional
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 30 to 70 years on the day of inclusion (30 to 70 years means from the day of the 30th birthday to the day before the 71st birthday)
- Body mass index < 40 kg/m2
- Participants without type 2 diabetes mellitus (T2DM) or pre-diabetes (as confirmed by hemoglobin A1C (HbA1c) < 5.7%) or Participants diagnosed with T2DM for at least 6 months with HbA1c between 6.5%-7.8% or 8%-10% on the day of screening
- Participants without PD (healthy or with gingivitis), or participants diagnosed with stages I/II or stages III/IV PD within 2 weeks of sample collection
Who cannot join
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating blood sampling
- History of human immunodeficiency virus (HIV) infection, or active hepatitis B (HB) or hepatitis C virus infection
- Known or recently active (within 12 months) neoplastic disease (including skin cancer) or a current or past diagnosis of any hematologic malignancy (ie, leukemia)
- Participants with pre-existing unstable disease, defined as disease requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks prior to enrollment
- Active autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc)
- Known pregnancy (no pregnancy testing will be performed)
Show all 14Show fewer
- Overt acute illness/infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C [100.4°F]) on the day of inclusion. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided for at least 2 consecutive days prior to enrollment
- Receipt of any vaccine within the 4 weeks preceding study enrollment
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Current or recent (within 3 weeks of enrollment) receipt of systemic antibiotics
- Use of chlorhexidine mouthwash for > 7 days within 3 weeks of enrollment
- Receipt of immunomodulators or immunosuppressive therapy, including long-term corticosteroid therapy
- Sub-gingival instrumentation/SRP within the 3 months prior to study enrollment
- Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UT Health Houston School of Dentistry- Site Number : 8400003
Houston, Texas, 77054
University of Iowa - Site Number : 8400002
Iowa City, Iowa, 52242
ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004
Somerville, Massachusetts, 02143
Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001
Stony Brook, New York, 11794
About this study
Official title: A Multi-center, Cross-sectional Study to Investigate Immunological, Clinical, and Microbiological Biomarkers in Well-characterized Populations With or Without Periodontitis and/or Type 2 Diabetes Mellitus in Male and Female Participants Aged 30 -70 Years
The purpose of this study is to learn about the interactions of markers of type 2 diabetes (T2DM) and periodontitis (PD). Study VPE00001 is a multi-center cross-sectional study. Participants will be categorized based on point-of-care hemoglobin A1c (HbA1c) and periodontal disease (PD) staging into 9 subgroups. The key objectives of the study are:
- To evaluate immune signatures in well-characterized populations with or without PD and/or T2DM
- To evaluate baseline clinical biomarkers of T2DM and PD in well-characterized populations
- To evaluate the influence of clinical, immunological, and microbiological biomarkers on the bidirectional relationship between T2DM and PD
Read the detailed description
The duration of each participant will be up to 30 days with a screening visit and a single visit for specimen collection.
- Conditions
- Periodontal Disease
- Being tested
- Investigational Procedure
- Keywords
- Type 2 diabetes mellitus, Porphyromonas gingivalis
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational ProcedureProcedure or surgery
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus | Other | Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected Receives: Procedure: Investigational Procedure |
| Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8 | Other | Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected Receives: Procedure: Investigational Procedure |
| Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0 | Other | Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected Receives: Procedure: Investigational Procedure |
| Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes Mellitus | Other | Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected Receives: Procedure: Investigational Procedure |
| Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8 | Other | Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected Receives: Procedure: Investigational Procedure |
| Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0 | Other | Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected Receives: Procedure: Investigational Procedure |
| Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes Mellitus | Other | Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected Receives: Procedure: Investigational Procedure |
| Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8 | Other | Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected Receives: Procedure: Investigational Procedure |
| Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0 | Other | Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected Receives: Procedure: Investigational Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab)
Measured: Day 01
Serum protease activity inhibition (PAI) titers
Measured: Day 01
Serum hemagglutination inhibition (HAI) titers
Measured: Day 01
Quantitative deoxyribonucleic acid (DNA)-based detection of Pg (saliva)
Measured: Day 01
DNA-based detection of Pg (sub-gingival plaque)
Measured: Day 01
Active-matrix metalloproteinase-8 (aMMP-8) levels measured by immunoassay in saliva (chairside assay)
Measured: Day 01
Secondary outcomes (7)
Levels of inflammatory mediators (for example, cytokines, chemokines, matrix metalloproteinases) in serum measured by multiplex assay
Measured: Day 01
Levels of inflammatory mediators in saliva (including MMP-8)
Measured: Day 01
Salivary titers of total anti-Pg Ab
Measured: Day 01
Measurement of high sensitivity C-reactive protein (hsCRP) in serum
Measured: Day 01
Measurement of serum levels of pro-insulin
Measured: Day 01
Measurement of serum levels of c-peptide
Measured: Day 01
Measurement of serum levels of prostaglandin E2 (PGE2)
Measured: Day 01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start9 Oct 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582056
- Sponsor's protocol ID
- VPE00001
- Other IDs
- U1111-1306-7393
- Status last verified
- Nov 2025
- First submitted
- 30 Jul 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Cross-sectional Study to Investigate Immunological, Clinical, and Microbiological Biomarkers in Well-characterized Populations With or Without Periodontitis and/or Type 2 Diabetes Mellitus in Male and Female Participants Aged 30 -70 Years
- ClinicalTrials.gov ID
- NCT06582056
- Acronym / sponsor ID
- VPE00001
- Conditions
- Periodontal Disease
- Keywords
- Type 2 diabetes mellitus, Porphyromonas gingivalis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 3 Sep 2024 (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.
The purpose of this study is to learn about the interactions of markers of type 2 diabetes (T2DM) and periodontitis (PD). Study VPE00001 is a multi-center cross-sectional study. Participants will be categorized based on point-of-care hemoglobin A1c (HbA1c) and periodontal disease (PD) staging into 9 subgroups. The key objectives of the study are:
- To evaluate immune signatures in well-characterized populations with or without PD and/or T2DM
- To evaluate baseline clinical biomarkers of T2DM and PD in well-characterized populations
- To evaluate the influence of clinical, immunological, and microbiological biomarkers on the bidirectional relationship between T2DM and PD
Detailed description
The duration of each participant will be up to 30 days with a screening visit and a single visit for specimen collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus | Other | Procedure: Investigational ProcedureParticipants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected |
| Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8 | Other | Procedure: Investigational ProcedureParticipants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected |
| Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0 | Other | Procedure: Investigational ProcedureParticipants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected |
| Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes Mellitus | Other | Procedure: Investigational ProcedureParticipants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected |
| Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8 | Other | Procedure: Investigational ProcedureParticipants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected |
| Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0 | Other | Procedure: Investigational ProcedureParticipants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected |
| Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes Mellitus | Other | Procedure: Investigational ProcedureParticipants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected |
| Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8 | Other | Procedure: Investigational ProcedureParticipants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected |
| Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0 | Other | Procedure: Investigational ProcedureParticipants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 30 to 70 years on the day of inclusion (30 to 70 years means from the day of the 30th birthday to the day before the 71st birthday)
- Body mass index < 40 kg/m2
- Participants without type 2 diabetes mellitus (T2DM) or pre-diabetes (as confirmed by hemoglobin A1C (HbA1c) < 5.7%) or Participants diagnosed with T2DM for at least 6 months with HbA1c between 6.5%-7.8% or 8%-10% on the day of screening
- Participants without PD (healthy or with gingivitis), or participants diagnosed with stages I/II or stages III/IV PD within 2 weeks of sample collection
Key exclusion criteria (14 listed)
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating blood sampling
- History of human immunodeficiency virus (HIV) infection, or active hepatitis B (HB) or hepatitis C virus infection
- Known or recently active (within 12 months) neoplastic disease (including skin cancer) or a current or past diagnosis of any hematologic malignancy (ie, leukemia)
- Participants with pre-existing unstable disease, defined as disease requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks prior to enrollment
- Active autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc)
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 |
|---|---|---|
| Investigational ProcedureIt consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration. | Procedure or surgery | Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8, Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0, Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus, Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8, Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0, Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes Mellitus, Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8, Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0, Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes Mellitus |
Primary outcome
Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab)
Time frame: Day 01
Serum protease activity inhibition (PAI) titers
Time frame: Day 01
Serum hemagglutination inhibition (HAI) titers
Time frame: Day 01
Quantitative deoxyribonucleic acid (DNA)-based detection of Pg (saliva)
Time frame: Day 01
DNA-based detection of Pg (sub-gingival plaque)
Time frame: Day 01
Active-matrix metalloproteinase-8 (aMMP-8) levels measured by immunoassay in saliva (chairside assay)
Time frame: Day 01
7 secondary outcomes
Levels of inflammatory mediators (for example, cytokines, chemokines, matrix metalloproteinases) in serum measured by multiplex assay
Time frame: Day 01
Levels of inflammatory mediators in saliva (including MMP-8)
Time frame: Day 01
Salivary titers of total anti-Pg Ab
Time frame: Day 01
Measurement of high sensitivity C-reactive protein (hsCRP) in serum
Time frame: Day 01
Measurement of serum levels of pro-insulin
Time frame: Day 01
Measurement of serum levels of c-peptide
Time frame: Day 01
Measurement of serum levels of prostaglandin E2 (PGE2)
Time frame: Day 01
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 28 Nov 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Procedure in people with Periodontal Disease, run by Sanofi Pasteur, a Sanofi Company at 4 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 4 inclusion and 14 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab) (time frame: Day 01). The study lists 6 primary outcomes in all. 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 28 Nov 2025.