study on biomarkers of periodontitis and type 2 diabetes mellitus in males and females 30 - 70 years of age

Conditions: Periodontal Disease

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

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

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.

Keywords: type 2 diabetes mellitus porphyromonas gingivalis