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Purpose

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

Condition

Eligibility

Eligible Ages
Between 30 Years and 70 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus 		Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
  • Procedure: Investigational 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.
Other
Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8 		Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
  • Procedure: Investigational 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.
Other
Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0 		Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
  • Procedure: Investigational 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.
Other
Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes Mellitus 		Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
  • Procedure: Investigational 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.
Other
Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8 		Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
  • Procedure: Investigational 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.
Other
Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0 		Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
  • Procedure: Investigational 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.
Other
Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes Mellitus 		Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
  • Procedure: Investigational 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.
Other
Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8 		Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
  • Procedure: Investigational 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.
Other
Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0 		Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
  • Procedure: Investigational 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.

Recruiting Locations

UT Health Houston School of Dentistry- Site Number : 8400003
Houston, Texas 77054

More Details

Status
Recruiting
Sponsor
Sanofi Pasteur, a Sanofi Company

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.