NCT06582056已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 8
- 主要终点
- Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab)
研究概览
简要总结
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
详细描述
The duration of each participant will be up to 30 days with a screening visit and a single visit for specimen collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Serum titers of total anti-Porphyromonas gingivalis (Pg) antibody (Ab)
时间窗: Day 01
Serum protease activity inhibition (PAI) titers
时间窗: Day 01
Serum hemagglutination inhibition (HAI) titers
时间窗: Day 01
Quantitative deoxyribonucleic acid (DNA)-based detection of Pg (saliva)
时间窗: Day 01
DNA-based detection of Pg (sub-gingival plaque)
时间窗: Day 01
Active-matrix metalloproteinase-8 (aMMP-8) levels measured by immunoassay in saliva (chairside assay)
时间窗: Day 01
次要结局
- Measurement of serum levels of pro-insulin(Day 01)
- Measurement of serum levels of c-peptide(Day 01)
- Measurement of serum levels of prostaglandin E2 (PGE2)(Day 01)
- Levels of inflammatory mediators in saliva (including MMP-8)(Day 01)
- Salivary titers of total anti-Pg Ab(Day 01)
- Measurement of high sensitivity C-reactive protein (hsCRP) in serum(Day 01)
- Levels of inflammatory mediators (for example, cytokines, chemokines, matrix metalloproteinases) in serum measured by multiplex assay(Day 01)
研究者
研究点 (8)
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