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

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

  • Periodontal Disease

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.