NCT06582056

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-09
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-09-03
• Last updated: 2025-11-28

Locations

4 sites across 1 country: United States