The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Glucose (OGTT)
研究概览
简要总结
This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.
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
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 14 and 18 years of age
- •Tanner stage 4 or 5 (mature adult stage of puberty)
- •Normal weight (BMI ≥ 5th percentile & < 85th percentile), overweight (BMI > 86th percentile) & < 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and/or pre-diabetes (HbA1c > 5.7%)
- •For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes
排除标准
- •Currently pregnant
- •Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management
- •Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff
- •Allergies or intolerance to milk, soy, or palm oil
研究组 & 干预措施
PreDiabetes
HbA1c > 5.7%
Type 2 Diabetes
Diagnosed with Type 2 Diabetes
Overweight
BMI > 86th percentile and <94th percentile
Normal weight
BMI ≥ 5th percentile & < 85th percentile
Obese weight
BMI ≥ 95th percentile
结局指标
主要结局
Glucose (OGTT)
时间窗: 120 minutes
Plasma Glucose (mg/dL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose
Insulin (MMTT)
时间窗: 180 minutes
Plasma Insulin (µU/mL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake.
Insulin (OGTT)
时间窗: 120 minutes
Plasma Insulin (µU/mL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose
Glucose (MMTT)
时间窗: 180 minutes
Plasma Glucose (mg/dL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake.
Monocyte /macrophage populations by flow cytometry
时间窗: 180 minutes
Frequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake
次要结局
- Free fatty acids (MMTT)(180 minutes)
- Triglycerides (MMTT)(180 minutes)
研究者
Kanakadurga Singer
Associate Professor
University of Michigan