Exploring the links between periodontitis and type 2 diabetes in adults aged 30 to 70
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
This study is trying to see how gum disease and type 2 diabetes are connected in adults aged 30 to 70 by looking at different health markers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 4 sites (Iowa City, Iowa and 3 other locations) |
| Trial ID | NCT06582056 on ClinicalTrials.gov |
What this trial studies
This study investigates the interactions between biomarkers of type 2 diabetes mellitus (T2DM) and periodontal disease (PD) in a multi-center cross-sectional design. Participants aged 30 to 70 will be categorized into nine subgroups based on their hemoglobin A1c (HbA1c) levels and PD staging. The study aims to evaluate immune signatures, clinical biomarkers, and the influence of various biomarkers on the relationship between T2DM and PD. Each participant will be involved for up to 30 days, including a screening visit and a single visit for specimen collection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 70 with or without type 2 diabetes and varying stages of periodontal disease.
Not a fit: Patients with bleeding disorders, active infections, or recent neoplastic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the relationship between periodontitis and type 2 diabetes, potentially leading to improved management strategies for these conditions.
How similar studies have performed: Other studies have explored the relationship between periodontal disease and diabetes, indicating potential for meaningful insights, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Iowa City, Iowa and 3 other locations
- University of Iowa - Site Number : 8400002 — Iowa City, Iowa, United States (Recruiting)
- ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004 — Somerville, Massachusetts, United States (Recruiting)
- Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001 — Stony Brook, New York, United States (Recruiting)
- UT Health Houston School of Dentistry- Site Number : 8400003 — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.