Hepatic Fat Content and Mitochondrial Flux in Obese Youth Before and After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Percentage of Liver Fat Per MRI
研究概览
简要总结
Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth
详细描述
A metabolic study that will be performed prior to and 12 months following bariatric surgery. The study will include 31-phosphorus magnetic resonance spectroscopy to measure phosphate concentrations in the liver; a 4 hour mixed meal tolerance test, an intravenous arginine test, Abdominal Magnetic Resonance Imaging (MRI) for visceral and hepatic fat, Magnetic Resonance (MR) Elastography of the liver, indirect calorimetry, body composition assessment with Bodpod, serum metabolomics and hepatic tissue mitochondrial measures from the time of surgery only.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese youth ages 13-20 years, scheduled for bariatric surgery at Children's Hospital Colorado
- •BMI 35-55 m2/kg
- •Maximal body circumference <200 cm
排除标准
- •Use of medications known to affect insulin sensitivity: oral glucocorticoids within 10; days, atypical antipsychotics, immunosuppressant agents, HIV medications.
- •Infectious hepatitis
- •Alcohol abuse
- •Mitochondrial disease
- •Type 2 diabetes
- •Medications that affect hepatic outcomes (e.g. PPAR-γ or PPAR-α, metformin)
- •Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
- •Severe illness requiring hospitalization within 60 days
- •Diabetes, defined as Hemoglobin A1C > 6.4%
- •Anemia, defined as Hemoglobin < 10 mg/dL
- •Diagnosed major psychiatric or developmental disorder limiting informed consent
- •Implanted metal devices that are not compatible with MRI
结局指标
主要结局
Change in Percentage of Liver Fat Per MRI
时间窗: Prior to bariatric surgery and 1 year post-bariatric surgery
Percentage of liver fat at 1 year post-bariatric surgery minus percentage of liver fat prior to bariatric surgery. Liver fat measured with MRI and calculated via the Dixon method as the proton density hepatic fat. A negative value means a decrease in liver fat after bariatric surgery.
Change in %Direct TG-Glycerol Appearance
时间窗: Prior to bariatric surgery and 1 year post-bariatric surgery
Change in %TG-Glycerol appearance from a labeled glycerol drink via direct pathway. TCA substrate cycling assessed via change in fractional direct glycerol carbon contributions to newly synthesized triglycerides using a U-13C glycerol tracer drink. A higher direct percentage is beneficial, indicating decreased oxidative stress resulting from excess glycerol metabolism through the TCA cycle.
次要结局
- Change in Insulin Sensitivity(Prior to bariatric surgery and 1 year post-bariatric surgery)
- Change in Peak Glucose(Prior to bariatric surgery and 1 year post-bariatric surgery)
- Change in Minimum Glucose(Prior to bariatric surgery and 1 year post-bariatric surgery)
- Change in Peak Insulin(Prior to bariatric surgery and 1 year post-bariatric surgery)
- Change in Minimum Insulin(Prior to bariatric surgery and 1 year post-bariatric surgery)
- Change in Peak C-peptide(Prior to bariatric surgery and 1 year post-bariatric surgery)
- Change in Peak GLP-1(Prior to bariatric surgery and 1 year post-bariatric surgery)
- Change in Fasting Glucagon(Prior to bariatric surgery and 1 year post-bariatric surgery)
- Change in Liver Stiffness Per MRI(Prior to bariatric surgery and 1 year post-bariatric surgery)
- Mitochondrial Function in the Liver Assessed by Oroboros(At the time of surgery)
- Hepatic Steatosis Score Via Tissue Biopsy(At the time of surgery)