Assessment of Hepatic Glucose and Fat Regulation in Overweight Adolescent Girls
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Hepatic Glucose Release
研究概览
简要总结
Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis compared to weight similar women with regular menses. It is unclear if this is related to high testosterone or insulin resistance. The investigators will assess hepatic glucose release, rates of lipolysis and hepatic de novo lipogenesis in the fasted and postprandial state to determine if alterations in the processes contribute to hepatic steatosis. Participants will be overweight, sedentary girls with or without PCOS. Those with PCOS will either be medication naive, or must be taking metformin or combined oral contraceptives (COCPs) for a period of at least 6 months prior to study procedures.
详细描述
Hepatic glucose release will be assessed with a stable isotope glycerol tracer, lipolysis with a glycerol tracer, and hepatic de novo lipogenesis with an acetate tracer. Data will be collected fasting and after a glucose challenge. The degree of hepatic steatosis and abdominal fat partitioning will be assessed with Magnetic Resonance Imaging (MRI), and total body composition with Dual-energy X-ray absorptiometry (DEXA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •2 years post-menarche
- •BMI percentile >90%
排除标准
- •Type 2 diabetes
- •Liver disease
- •Medications known to effect insulin sensitivity
- •Cause of oligomenorrhea or hirsutism other than PCOS,
- •>3 hours a week of moderate exercise.
研究组 & 干预措施
PCOS, medication naive + Byetta
PCOS, medication naive; 10 girls with PCOS will receive 2 doses of Byetta.
干预措施: Byetta 5Mcg Pen Injection (Drug)
结局指标
主要结局
Hepatic Glucose Release
时间窗: Measured up to 4 months from enrollment
Hepatic glucose release will be measured by the rate of appearance of a glucose tracer. Glucose rate of appearance reflects the amount of glucose being release by primarily the liver during fasting. A higher glucose rate of appearance is often seen with dysglycemia
次要结局
- Hepatic Fat Fraction(Measured up to 4 months from enrollment)
- Hepatic Phosphate Concentrations(Measured up to 4 months from enrollment)
- Rates of Lipolysis(Measured up to 4 months from enrollment)
- Hepatic de Novo Lipogenesis(Measured up to 4 months from enrollment)