NCT05501093已完成不适用
Diabetes Reversal and the Subgingival Microbiota
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Bacterial composition
研究概览
简要总结
This study seeks to examine the impact of bariatric surgery on oral bacteria in diabetic compared to non-diabetic patients. The purpose of this research study is to examine how diabetes changes the bacteria in the mouth. This is an important question since bacterial changes may impact oral health. Participants will attend a screening and baseline visit prior to bariatric surgery and three post bariatric surgery appointments (3 weeks post, 6 months post and 1 year to 18 months post). Samples collected at each study visit include blood, plaque, and other oral samples. At the last study visit there is an optional dental cleaning.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women undergoing bariatric surgery who are 25-65 years old.
- •BMI > 35 kg/m
- •Diabetic subjects: HbA1c> 6.0% or fasting plasma glucose >126 mg/dl).
- •Normoglycemic subjects: HbA1c<5.75% or fasting plasma glucose <100 mg/dl).
- •Dental criteria: Minimum of 4 posterior teeth.
- •Signed and dated informed consent form.
- •Willing to comply with all study procedures and be available for the duration of the study.
排除标准
- •Subjects diagnosed with type 1 diabetes, maturity onset diabetes of the young (MODY), or latent autoimmune diabetes in adults (LADA).
- •Women who are considering pregnancy or are currently breastfeeding.
- •Individuals with a history of chronic inflammatory or autoimmune diseases or taking medications that affect immune function or affect body weight such as chronic systemic steroids.
- •Currently smoke more than 10 cigarettes per day.
- •Periodontal treatment within 3 months of bacterial sampling.
- •Acute periodontal infection (abscess) within 1 month of bacterial sampling or abscess in teeth or adjacent teeth within 1 month of sampling.
- •Treatment with antibiotics within one month of sample collection (except as part of the surgical regimen of prophylactic antibiotic immediately prior to surgery).
- •A treatment regimen of steroids within 1 month of sample collection.
结局指标
主要结局
Bacterial composition
时间窗: 18 months
as determined by 16s rRNA community profiling
次要结局
- Bacterial mRNA profiling(18 months)
- Gingival inflammation(18 mos.)
研究者
研究点 (2)
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