Clinical trial NCT06582056: Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age
Official title: A Multi-center, Cross-sectional Study to Investigate Immunological, Clinical, and Microbiological Biomarkers in Well-characterized Populations With or Without Periodontitis and/or Type 2 Diabetes Mellitus in Male and Female Participants Aged 30 -70 Years
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Disease
Keywords: Type 2 diabetes mellitus
Porphyromonas gingivalis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab)
timeFrame: Day 01
measure: Serum protease activity inhibition (PAI) titers
timeFrame: Day 01
measure: Serum hemagglutination inhibition (HAI) titers
timeFrame: Day 01
measure: Quantitative deoxyribonucleic acid (DNA)-based detection of Pg (saliva)
timeFrame: Day 01
measure: DNA-based detection of Pg (sub-gingival plaque)
timeFrame: Day 01
measure: Active-matrix metalloproteinase-8 (aMMP-8) levels measured by immunoassay in saliva (chairside assay)
timeFrame: Day 01
Secondary outcomes:
measure: Levels of inflammatory mediators (for example, cytokines, chemokines, matrix metalloproteinases) in serum measured by multiplex assay
timeFrame: Day 01
measure: Levels of inflammatory mediators in saliva (including MMP-8)
timeFrame: Day 01
measure: Salivary titers of total anti-Pg Ab
timeFrame: Day 01
measure: Measurement of high sensitivity C-reactive protein (hsCRP) in serum
timeFrame: Day 01
measure: Measurement of serum levels of pro-insulin
timeFrame: Day 01
measure: Measurement of serum levels of c-peptide
timeFrame: Day 01
measure: Measurement of serum levels of prostaglandin E2 (PGE2)
timeFrame: Day 01
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa - Site Number : 8400002
state: Iowa
city: Somerville
country: United States
facility: ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004
state: Massachusetts
city: Stony Brook
country: United States
facility: Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001
state: New York
city: Houston
country: United States
facility: UT Health Houston School of Dentistry- Site Number : 8400003
state: Texas
Study officials:
References: