Investigational Procedure for Type 2 Diabetes and Gum Disease
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulants, systemic antibiotics, immunomodulators, or long-term corticosteroids, you may need to stop them before joining the study.
What data supports the effectiveness of the treatment for Type 2 Diabetes and Gum Disease?
Is the investigational procedure for type 2 diabetes and gum disease safe for humans?
The studies reviewed focus on non-surgical periodontal treatments for people with type 2 diabetes and gum disease, which are generally considered safe. These treatments have been evaluated for their effects on gum health and blood sugar control, but no specific safety concerns were reported in the studies.12467
How is the investigational treatment for type 2 diabetes and gum disease different from other treatments?
The investigational treatment is unique because it focuses on the relationship between type 2 diabetes and gum disease, potentially addressing both conditions simultaneously. Unlike standard treatments that may target only one condition, this approach could improve oral health and help manage diabetes by reducing inflammation and improving metabolic control.14789
What is the purpose of this trial?
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
Eligibility Criteria
This study is for men and women aged 30-70 with a BMI under 40. It's open to those without diabetes or pre-diabetes, as well as those who've had type 2 diabetes for at least six months. Participants can also have varying stages of gum disease but must meet specific criteria based on their hemoglobin A1c levels.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Specimen Collection
Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) are collected from participants
Follow-up
Participants are monitored for safety and effectiveness after specimen collection
Treatment Details
Interventions
- Investigational Procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi Pasteur, a Sanofi Company
Lead Sponsor
Paul Hudson
Sanofi Pasteur, a Sanofi Company
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Dr. Thomas Triomphe
Sanofi Pasteur, a Sanofi Company
Chief Medical Officer since 2020
MD from Tehran University of Medical Sciences