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

The duration of each participant will be up to 30 days with a screening visit and a single visit for specimen collection.

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.