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

Sanofi

Status: Completed

Conditions: Periodontal Disease

Treatments: Procedure: Investigational Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT06582056

VPE00001 (Other Identifier)

U1111-1306-7393 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment: 226 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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226 participants in 9 patient groups

Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus

Other group

Description:

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

Treatment:

Procedure: Investigational Procedure

Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8

Other group

Description:

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

Treatment:

Procedure: Investigational Procedure

Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0

Other group

Description:

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

Treatment:

Procedure: Investigational Procedure

Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes Mellitus

Other group

Description:

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

Treatment:

Procedure: Investigational Procedure

Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8

Other group

Description:

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

Treatment:

Procedure: Investigational Procedure

Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0

Other group

Description:

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

Treatment:

Procedure: Investigational Procedure

Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes Mellitus

Other group

Description:

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

Treatment:

Procedure: Investigational Procedure

Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8

Other group

Description:

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

Treatment:

Procedure: Investigational Procedure

Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0

Other group

Description:

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

Treatment:

Procedure: Investigational Procedure