Periodontal Disease
Conditions
Keywords
Type 2 diabetes mellitus, Porphyromonas gingivalis
Brief 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
Detailed description
The duration of each participant will be up to 30 days with a screening visit and a single visit for specimen collection.
Interventions
PROCEDUREInvestigational Procedure
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab) | Day 01 |
| Serum protease activity inhibition (PAI) titers | Day 01 |
| Serum hemagglutination inhibition (HAI) titers | Day 01 |
| Quantitative deoxyribonucleic acid (DNA)-based detection of Pg (saliva) | Day 01 |
| DNA-based detection of Pg (sub-gingival plaque) | Day 01 |
| Active-matrix metalloproteinase-8 (aMMP-8) levels measured by immunoassay in saliva (chairside assay) | Day 01 |
Secondary
| Measure | Time frame |
|---|---|
| Levels of inflammatory mediators (for example, cytokines, chemokines, matrix metalloproteinases) in serum measured by multiplex assay | Day 01 |
| Measurement of serum levels of prostaglandin E2 (PGE2) | Day 01 |
| Levels of inflammatory mediators in saliva (including MMP-8) | Day 01 |
| Salivary titers of total anti-Pg Ab | Day 01 |
| Measurement of high sensitivity C-reactive protein (hsCRP) in serum | Day 01 |
| Measurement of serum levels of pro-insulin | Day 01 |
| Measurement of serum levels of c-peptide | Day 01 |
Countries
United States
Outcome results
None listed