NCT06582056Completed
Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age
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
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 226 (actual)
- First submitted
- 30 Jul 2024
- Start date
- 9 Oct 2024
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT06582056
What you commit to
- Study type: Interventional
- Participants enrolled: 226
- From 9 Oct 2024 to the primary completion date, 30 Sept 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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 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.
Other illness
- 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)
- Active autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc)
Other
- Known pregnancy (no pregnancy testing will be performed)
- 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
Who the study is looking for
- 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
Age in the registry: 30 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Health Houston School of Dentistry- Site Number : 8400003 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Iowa - Site Number : 8400002 Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004 Coordinator of this site? Confirm its status | Somerville | United States | Unknown status |
| Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001 Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.