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

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Sanofi Pasteur, a Sanofi Company
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Updated on 14 May 2025
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Accepts healthy volunteers

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

Description

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

Details
Condition Periodontal Disease
Age 30years - 70years
Clinical Study IdentifierNCT06582056
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on14 May 2025

Eligibility

 Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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