Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age

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

Study Overview

• Status: Completed
• Conditions: Periodontal Disease
• Intervention / Treatment: Procedure: Investigational Procedure

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 Type: Interventional
• Enrollment (Actual): 226
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa - Site Number : 8400002
  • Massachusetts
    • Somerville, Massachusetts, United States, 02143
      • ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001
  • Texas
    • Houston, Texas, United States, 77054
      • UT Health Houston School of Dentistry- Site Number : 8400003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus; 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	Procedure: Investigational Procedure; 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.
Other: Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8; 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	Procedure: Investigational Procedure; 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.
Other: Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0; 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	Procedure: Investigational Procedure; 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.
Other: Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes Mellitus; 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	Procedure: Investigational Procedure; 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.
Other: Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8; 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	Procedure: Investigational Procedure; 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.
Other: Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0; 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	Procedure: Investigational Procedure; 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.
Other: Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes Mellitus; 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	Procedure: Investigational Procedure; 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.
Other: Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8; 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	Procedure: Investigational Procedure; 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.
Other: Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0; 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	Procedure: Investigational Procedure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab)	Day 01
Serum protease activity inhibition (PAI) titers	Day 01
Serum hemagglutination inhibition (HAI) titers	Day 01
Quantitative deoxyribonucleic acid (DNA)-based detection of Pg (saliva)	Day 01
DNA-based detection of Pg (sub-gingival plaque)	Day 01
Active-matrix metalloproteinase-8 (aMMP-8) levels measured by immunoassay in saliva (chairside assay)	Day 01

Secondary Outcome Measures

Outcome Measure	Time Frame
Levels of inflammatory mediators (for example, cytokines, chemokines, matrix metalloproteinases) in serum measured by multiplex assay	Day 01
Levels of inflammatory mediators in saliva (including MMP-8)	Day 01
Salivary titers of total anti-Pg Ab	Day 01
Measurement of high sensitivity C-reactive protein (hsCRP) in serum	Day 01
Measurement of serum levels of pro-insulin	Day 01
Measurement of serum levels of c-peptide	Day 01
Measurement of serum levels of prostaglandin E2 (PGE2)	Day 01

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; Porphyromonas gingivalis
• Additional Relevant MeSH Terms: Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Periodontal Diseases
• Other Study ID Numbers: VPE00001 (Sanofi Identifier); U1111-1306-7393 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No