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

NCT06582056

CompletedNA

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Periodontal Disease

Interventions: Investigational Procedure

Countries: United States

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 overview

Sex: ALL

Age: 30 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (4)

Iowa City, Iowa, United States
Somerville, Massachusetts, United States
Stony Brook, New York, United States
Houston, Texas, United States