Status:
COMPLETED
Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Periodontal Disease
Eligibility:
All Genders
30-70 years
Phase:
NA
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 c...
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
- 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
- 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.
Key Trial Info
Start Date :
October 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT06582056
Start Date
October 9 2024
End Date
September 30 2025
Last Update
November 28 2025
Active Locations (4)
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1
University of Iowa - Site Number : 8400002
Iowa City, Iowa, United States, 52242
2
ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004
Somerville, Massachusetts, United States, 02143
3
Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001
Stony Brook, New York, United States, 11794
4
UT Health Houston School of Dentistry- Site Number : 8400003
Houston, Texas, United States, 77054