[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560815":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":44,"centralContacts":44,"locations":45,"responsibleParty":89,"collaborators":44,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":44,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":44,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":114,"whyStopped":44,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14,17,20,23,26,29,32,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus","OTHER","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",[13],"Procedure: Investigational Procedure",{"label":15,"type":10,"description":11,"interventionNames":16},"Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Participant with Stage I\u002FStage II Periodontal Disease with no Type 2 Diabetes Mellitus",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"Participant with Stage I\u002FStage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"Participant with Stage I\u002FStage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0",[13],{"label":30,"type":10,"description":11,"interventionNames":31},"Participant with Stage III\u002FStage IV Periodontal Disease with no Type 2 Diabetes Mellitus",[13],{"label":33,"type":10,"description":11,"interventionNames":34},"Participant with Stage III\u002FStage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8",[13],{"label":36,"type":10,"description":11,"interventionNames":37},"Participant with Stage III\u002FStage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0",[13],[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"PROCEDURE","Investigational Procedure","It consists of prospective blood and\u002For tissue collection from healthy subjects and\u002For patients with the appropriate clinical annotation. Study without any IMP administration.",[15,18,9,24,27,21,33,36,30],null,[46,59,69,79],{"facility":47,"status":44,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":44},"University of Iowa - Site Number : 8400002","Iowa City","Iowa","52242","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-91.53017,41.66113,{"lat":57,"lon":56},{"facility":60,"status":44,"city":61,"state":62,"zip":63,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":68,"contacts":44},"ADA Forsyth Institute Center for Clinical and Translational Research - Site Number : 8400004","Somerville","Massachusetts","02143",{"type":54,"coordinates":65},[66,67],-71.0995,42.3876,{"lat":67,"lon":66},{"facility":70,"status":44,"city":71,"state":72,"zip":73,"country":51,"countryCode":52,"cosmosGeoPoint":74,"geoPoint":78,"contacts":44},"Stony Brook School of Dental Medicine Periodontics Department- Site Number : 8400001","Stony Brook","New York","11794",{"type":54,"coordinates":75},[76,77],-73.14094,40.92565,{"lat":77,"lon":76},{"facility":80,"status":44,"city":81,"state":82,"zip":83,"country":51,"countryCode":52,"cosmosGeoPoint":84,"geoPoint":88,"contacts":44},"UT Health Houston School of Dentistry- Site Number : 8400003","Houston","Texas","77054",{"type":54,"coordinates":85},[86,87],-95.36327,29.76328,{"lat":87,"lon":86},{"type":90,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100560815","study-on-biomarkers-of-periodontitis-and-type-2-diabetes-mellitus-in-males-and-females-30---70-years-of-age-100560815",false,"NCT06582056","Study on Biomarkers of Periodontitis and Type 2 Diabetes Mellitus in Males and Females 30 - 70 Years of Age","A Multi-center, Cross-sectional Study to Investigate Immunological, Clinical, and Microbiological Biomarkers in Well-characterized Populations With or Without Periodontitis and\u002For Type 2 Diabetes Mellitus in Male and Female Participants Aged 30 -70 Years","Inclusion Criteria:\n\n* 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)\n* Body mass index \\\u003C 40 kg\u002Fm2\n* Participants without type 2 diabetes mellitus (T2DM) or pre-diabetes (as confirmed by hemoglobin A1C (HbA1c) \\\u003C 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\n* Participants without PD (healthy or with gingivitis), or participants diagnosed with stages I\u002FII or stages III\u002FIV PD within 2 weeks of sample collection\n\nExclusion Criteria:\n\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating blood sampling\n* History of human immunodeficiency virus (HIV) infection, or active hepatitis B (HB) or hepatitis C virus infection\n* Known or recently active (within 12 months) neoplastic disease (including skin cancer) or a current or past diagnosis of any hematologic malignancy (ie, leukemia)\n* 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\n* Active autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc)\n* Known pregnancy (no pregnancy testing will be performed)\n* Overt acute illness\u002Finfection (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\n* Receipt of any vaccine within the 4 weeks preceding study enrollment\n* Receipt of immune globulins, blood, or blood-derived products in the past 3 months\n* Current or recent (within 3 weeks of enrollment) receipt of systemic antibiotics\n* Use of chlorhexidine mouthwash for \\> 7 days within 3 weeks of enrollment\n* Receipt of immunomodulators or immunosuppressive therapy, including long-term corticosteroid therapy\n* Sub-gingival instrumentation\u002FSRP within the 3 months prior to study enrollment\n\nNote: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",true,"ALL","30 Years","70 Years",{"count":103,"type":104},226,"ACTUAL","INTERVENTIONAL",[107],"NA","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:\n\n* To evaluate immune signatures in well-characterized populations with or without PD and\u002For T2DM\n* To evaluate baseline clinical biomarkers of T2DM and PD in well-characterized populations\n* To evaluate the influence of clinical, immunological, and microbiological biomarkers on the bidirectional relationship between T2DM and PD",[110],"Periodontal Disease",[112,113],"Type 2 diabetes mellitus","Porphyromonas gingivalis","COMPLETED","2025-11-26",{"date":117,"type":104},"2025-11-28",{"date":119,"type":104},"2024-10-09",{"date":121,"type":104},"2025-09-30",{"name":123,"class":6},"Sanofi Pasteur, a Sanofi Company",4]