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

Investigating the Relationship between Type 2 Diabetes and Periodontitis (Gum Disease)

Recruiting
30 years - 70 years
All
Phase N/A
300 participants needed
4 Locations

Study Overview

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

Study Details

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Periodontal Disease
  • Age: 30 years - 70 years
  • Gender: All

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.

Updated on 25 Mar 2025. Study ID: NCT06582056

This study investigates the interactions between type 2 diabetes (T2DM) and periodontitis (PD), which is a serious gum infection that can damage gums and destroy the jawbone. The purpose is to understand how these two conditions affect each other. Participants will be divided into nine different study arms based on their blood sugar levels and the stage of their gum disease.

In this study, participants will have a screening visit followed by one visit for specimen collection. During the study, researchers will evaluate immune markers and clinical biomarkers related to T2DM and PD. These biomarkers are substances in the body that can indicate disease or health conditions.

  • Who can participate: Adults aged 30 to 70 years with a body mass index under 40 kg/m2 can participate. Participants may have type 2 diabetes, pre-diabetes, or be without diabetes, and may have healthy gums, gingivitis, or varying stages of periodontitis.
  • Study details: Participants will attend a screening visit and one additional visit for specimen collection. The study will examine immune markers and clinical biomarkers related to diabetes and gum disease.
  • Study Timelines and Visits: The study will last 30 days. The study requires 2 visits.

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