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

NCT06582056 | Completed

• 2 other identifiers: VPE00001U1111-1306-7393
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 4

Brief 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. 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

Conditions

Periodontal Disease

Keywords

Type 2 diabetes mellitus; Porphyromonas gingivalis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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

Study Arms (9)

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

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

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

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

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

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

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

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

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

Procedure: Investigational Procedure

Interventions

Investigational Procedure 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.

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

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (4)

University of Iowa - Site Number : 8400002

Iowa City, Iowa, 52242, United States

Location

ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004

Somerville, Massachusetts, 02143, United States

Location

Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001

Stony Brook, New York, 11794, United States

Location

UT Health Houston School of Dentistry- Site Number : 8400003

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Periodontal Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: September 3, 2024
• Study Start: October 9, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (4)