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

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to understand how type 2 diabetes (T2DM) and periodontal disease (PD) are related. Researchers want to learn about specific markers in the body that can show whether someone has T2DM or PD and how these conditions might affect each other. The study will include men and women aged 30 to 70 years old, and participants will be grouped based on their diabetes status and the severity of their gum disease.

To be eligible for this study, participants should be within the specified age range and have a body mass index (BMI) of less than 40. They should either not have T2DM or pre-diabetes, or they should have a diagnosis of T2DM for at least six months. Participants must also have either healthy gums or certain stages of gum disease. If you join the study, you can expect to provide some health information and possibly some samples, which will help researchers learn more about the connection between diabetes and gum disease. Please note that there are specific health conditions that would exclude someone from participating, such as active infections or certain chronic diseases.

Gender

ALL

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.