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
The duration of each participant will be up to 30 days with a screening visit and a single visit for specimen collection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
226
It consists of prospective blood and/or tissue collection from healthy subjects and/or patients with the appropriate clinical annotation. Study without any IMP administration.
University of Iowa - Site Number : 8400002
Iowa City, Iowa, United States
ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004
Somerville, Massachusetts, United States
Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001
Stony Brook, New York, United States
UT Health Houston School of Dentistry- Site Number : 8400003
Houston, Texas, United States
Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab)
Time frame: Day 01
Serum protease activity inhibition (PAI) titers
Time frame: Day 01
Serum hemagglutination inhibition (HAI) titers
Time frame: Day 01
Quantitative deoxyribonucleic acid (DNA)-based detection of Pg (saliva)
Time frame: Day 01
DNA-based detection of Pg (sub-gingival plaque)
Time frame: Day 01
Active-matrix metalloproteinase-8 (aMMP-8) levels measured by immunoassay in saliva (chairside assay)
Time frame: Day 01
Levels of inflammatory mediators (for example, cytokines, chemokines, matrix metalloproteinases) in serum measured by multiplex assay
Time frame: Day 01
Levels of inflammatory mediators in saliva (including MMP-8)
Time frame: Day 01
Salivary titers of total anti-Pg Ab
Time frame: Day 01
Measurement of high sensitivity C-reactive protein (hsCRP) in serum
Time frame: Day 01
Measurement of serum levels of pro-insulin
Time frame: Day 01
Measurement of serum levels of c-peptide
Time frame: Day 01
Measurement of serum levels of prostaglandin E2 (PGE2)
Time frame: Day 01
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