Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age
Study on the Effect of an Investigational Medication on Diabetes and Gum Disease
Brief description of study
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 of study
The duration of each participant will be up to 30 days with a screening visit and a single visit for specimen collection.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Periodontal Disease
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Age: 30 years - 70 years
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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.
This study investigates the effects of an investigational medication on individuals with Type 2 Diabetes Mellitus (T2DM) and periodontal disease (PD). Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels. Periodontal disease, also known as gum disease, is an infection of the tissues that hold your teeth in place. The study aims to understand how these conditions interact with the investigational medication.
Participants will undergo a screening visit followed by a single visit for specimen collection. During the study, participants will be monitored for changes in their condition and any effects of the investigational medication. The study will involve collecting samples to assess the impact of the treatment on diabetes and periodontal health.
- Who can participate: Adults aged 30 to 70 years with a body mass index less than 40 kg/m2 are eligible. Participants must not have pre-diabetes and should have specific stages of periodontal disease or Type 2 Diabetes Mellitus for at least 6 months.
- Study details: The study involves monitoring changes in health conditions and the effects of the investigational medication. A placebo may also be used.
- Study Timelines and Visits: The study will last up to 30 days. The study requires 2 visits.
