The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Analysis of gut microbial composition and diversity by 16S rRNA sequencing
研究概览
简要总结
This study employs a cross-sectional design to profile the gut microbiome and urine metabolome in overweight/obese children with type 1 diabetes (T1D).
详细描述
The investigators will obtain stool and urine samples from subjects aged 7-17 years in 4 groups:
- Group 1: Obese or overweight children within 3 years of diagnosis of T1D
- Group 2: Normal weight children within 3 years of diagnosis of T1D
- Group 3: Obese or overweight children without T1D
- Group 4: Normal weight children without T1D
Type 1 diabetes will be defined according to American Diabetes Association criteria along with the presence of pancreatic autoantibodies (GAD65, ICA512, or insulin autoantibodies). Obese and overweight status will be defined by BMI >85th percentile for age and gender according to CDC criteria.
All subjects will provide one-time stool and first morning urine sample. Overweight or obese subjects will additionally have a point of care blood glucose and hemoglobin A1c measurement to ensure that they do not have diabetes.
The investigators will perform 16S rRNA sequencing of stool bacteria and mass spectrometry measurement of urine metabolites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 7 to 17 years
- •Diagnosis of diabetes will be defined by current American Diabetes Association criteria ° (fasting glucose > 126 mg/dl, 2 hour OGTT glucose > 200 mg/dl; random glucose > 200 with symptoms of hyperglycemia; or HbA1c > 6.5%)
- •Diabetes duration < 3 years
- •Presence of pancreatic autoimmunity (GAD65, ICA512, or insulin autoantibody positivity)
- •Adult caregiver willing to actively support study participation
- •Signed parental informed consent form and minor child informed assent form
排除标准
- •Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation
结局指标
主要结局
Analysis of gut microbial composition and diversity by 16S rRNA sequencing
时间窗: 2 years
次要结局
- Analysis of urine metabolite concentrations measured by mass spectrometry(2 years)
研究者
Dr Jane Kim
Assistant Professor
University of California, San Diego