COMPLETED

Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age

Conditions

Periodontal Disease Type 2 diabetes mellitus Porphyromonas gingivalis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-10-09

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06582056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

University of Iowa - Site Number : 8400002

Iowa City, Iowa, 52242

United States

ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004

Somerville, Massachusetts, 02143

United States

Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001

Stony Brook, New York, 11794

United States

UT Health Houston School of Dentistry- Site Number : 8400003

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: Sanofi Pasteur, a Sanofi Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-09

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-10-09

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

Type 2 diabetes mellitus
Porphyromonas gingivalis

Additional Relevant MeSH Terms

Periodontal Disease