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

NCT06582056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2025-11-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06582056 on ClinicalTrials.gov