Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582056
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-center Cross-sectional Study to Investigate Immunological Clinical and Microbiological Biomarkers in Well-characterized Populations With or Without Periodontitis andor Type 2 Diabetes Mellitus in Male and Female Participants Aged 30 -70 Years
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 andor 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
To evaluate immune signatures in well-characterized populations with or without PD andor 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
Detailed Description:
The duration of each participant will be up to 30 days with a screening visit and a single visit for specimen collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None