Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age
Not Applicable
Recruiting
- Conditions
- Periodontal Disease
- Interventions
- Procedure: Investigational Procedure
- Registration Number
- NCT06582056
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief 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
- Detailed Description
The duration of each participant will be up to 30 days with a screening visit and a single visit for specimen collection.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8 Investigational Procedure 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 Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus Investigational Procedure 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 Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0 Investigational Procedure 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 Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes Mellitus Investigational Procedure 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 Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8 Investigational Procedure 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 Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0 Investigational Procedure 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 Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes Mellitus Investigational Procedure 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 Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8 Investigational Procedure 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 Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0 Investigational Procedure 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
- Primary Outcome Measures
Name Time Method Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab) Day 01 Serum protease activity inhibition (PAI) titers Day 01 Serum hemagglutination inhibition (HAI) titers Day 01 Quantitative deoxyribonucleic acid (DNA)-based detection of Pg (saliva) Day 01 DNA-based detection of Pg (sub-gingival plaque) Day 01 Active-matrix metalloproteinase-8 (aMMP-8) levels measured by immunoassay in saliva (chairside assay) Day 01
- Secondary Outcome Measures
Name Time Method Measurement of serum levels of pro-insulin Day 01 Measurement of serum levels of c-peptide Day 01 Measurement of serum levels of prostaglandin E2 (PGE2) Day 01 Levels of inflammatory mediators in saliva (including MMP-8) Day 01 Salivary titers of total anti-Pg Ab Day 01 Measurement of high sensitivity C-reactive protein (hsCRP) in serum Day 01 Levels of inflammatory mediators (for example, cytokines, chemokines, matrix metalloproteinases) in serum measured by multiplex assay Day 01
Trial Locations
- Locations (4)
University of Iowa - Site Number : 8400002
🇺🇸Iowa City, Iowa, United States
ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004
🇺🇸Somerville, Massachusetts, United States
Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001
🇺🇸Stony Brook, New York, United States
UT Health Houston School of Dentistry- Site Number : 8400003
🇺🇸Houston, Texas, United States