NCT00860392已完成1 期
A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in healthy lean subjects
研究概览
简要总结
This study will compare two approaches to the measurement of fatty acid oxidation (ketone body flux and ketone body concentration) and determine which method demonstrates superior sensitivity and variability in the detection of moderate increases in ketogenesis rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject has a Body Mass Index of 18-25 kg/m2 OR 29-40 kg/m2
- •Subject has been a nonsmoker or has not used nicotine for the past 6 months
排除标准
- •Subject has a history of diabetes mellitus
- •Subject has a history of stroke, chronic seizures, or other neurological disorder
- •Subject has a history of cancer, except certain skin cancers
- •Subject consumes more than 3 alcoholic beverages per day
- •Subject consumes more than 6 servings of caffeinated beverages per day
- •Subject has multiple and/or severe allergies to food or drugs
- •Subject has allergy or sensitivity to eggs or soy
- •Subject regularly uses illicit drugs or has a history of drug or alcohol abuse
研究组 & 干预措施
1
Experimental
Biomarker evaluation
干预措施: Stable isotope tracer (13-C(4)-BHB) (Drug)
结局指标
主要结局
Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in healthy lean subjects
时间窗: 5 hours
次要结局
- Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in obese subjects(5 hours)
研究者
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