Alcohol Induced de Novo Lipogenesis in Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Mean Change in Hepatic De Novo Lipogenesis (DNL)
研究概览
简要总结
The study is cross-sectional is design. In the first Aim of this study, 5 women and 5 men will be asked to consume 2g/kg of [2H]water (a.k.a. deuterium oxide or heavy water) which incorporates 2H tracers into newly synthesized fatty acids and triglycerides. Deuterated water is not radioactive and has a long history of application in human studies. Researchers will collect blood samples 2 hours before and 5 hours after the participants consume 20 grams of alcohol as vodka to measure alcohol induced hepatic de novo lipogenesis (DNL) in both men in women. In addition, for Aim 2 researchers will recruit an additional 10 women who will be randomized into one of two groups who will consume a beverage containing vodka and sucrose, or sucrose alone. Aim 2 will be identical to the experimental scheme in Aim 2 in order to determine if sucrose enhances the effects of vodka on hepatic DNL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Ages 21 - 45
- •Light to moderate alcohol consumption (≤1 drink a day (~14g) in women and ≤2 drinks a day (~28 g) in men)
- •BMI between 18.5-29.9
- •Normal Nutritional Status
- •Ability to speak and understand English
排除标准
- •BMI >29.9
- •Comorbid conditions
- •Any regular medications, except Oral Contraceptives
- •Pregnant or Breastfeeding
- •Regular exercise above activities of daily living
研究组 & 干预措施
A. ETOH
5 Males and 5 Females will receive deuterated water and drink 2.15 ounces of alcohol in the form of vodka and have de novo Lipogenesis measured at 11 time points during and after.
干预措施: ETOH (Other)
ETOH + Sucrose
5 Females will receive deuterated water and drink 1.72 ounces of alcohol in the form of vodka + 7 grams of sucrose and have de novo Lipogenesis measured at 11 time points during and after.
干预措施: ETOH (Other)
结局指标
主要结局
Mean Change in Hepatic De Novo Lipogenesis (DNL)
时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours post heavy water consumption
DNL will be measured by Orbitrap high-resolution-mass-spectrometry (GC-Orbitrap-HRMS) We will measure changes in the incorporation of 2H tracers into plasma triglycerides over time. This data will be analyzed by averaging each time point and looking at change in de novo lipogenesis over time.
次要结局
未报告次要终点
研究者
Justin Fletcher
Assistant Professor
University of Texas Southwestern Medical Center