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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: t
View:
• 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
Locations
United States
Iowa
University of Iowa - Site Number : 8400002
ACTIVE_NOT_RECRUITING
Iowa City
Massachusetts
ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004
ACTIVE_NOT_RECRUITING
Somerville
New York
Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001
ACTIVE_NOT_RECRUITING
Stony Brook
Texas
UT Health Houston School of Dentistry- Site Number : 8400003
RECRUITING
Houston
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date:2024-10-09
Estimated Completion Date:2025-10-30
Participants
Target number of participants:300
Treatments
Other: Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Other: Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Other: Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Other: Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes Mellitus
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Other: Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Other: Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Other: Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes Mellitus
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Other: Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Other: Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected