Fructose: Substrate, Stimulus, or Both?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Hepatic fractional de novo lipogenesis in triglyceride rich lipoprotein (TRL)
研究概览
简要总结
This objective of this study is to use sensitive methodology under controlled conditions to investigate the mechanisms by which fructose consumption contributes to excess fatty acid synthesis and elevations in blood glucose levels following consumption of meals containing fructose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index 22 to 35 kg/m2
- •Prediabetic (HbA1c 5.7% to 6.5%) or hyperinsulinemic (fasting insulin ≥12 µIU/mL) but non-diabetic (fasting glucose <126mg/dL and HbA1c < 6.5%) ; or normal control (fasting insulin <10 µIU/mL, fasting glucose <100 mg/dL, and HbA1c < 5.7%)
排除标准
- •Pregnancy or lactation within the past six months
- •Type 1 or 2 diabetes mellitus
- •History of liver disease or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2x the upper limit of normal (ULN);
- •Fasting triglyceride or total cholesterol levels above 95th percentile for age and sex;
- •Hemoglobin or hematocrit below the lower limit of normal for sex;
- •Report of hepatitis or HIV infection;
- •History of cancer, use of any anti-diabetic medications or hypolipidemic agents in the past six months;
- •History of surgical procedure for obesity;
- •Self-reported change in body weight >5% in the past six months;
- •History of other conditions known to affect insulin sensitivity and lipid metabolism;
- •Known intolerance to acetaminophen or components of the liquid test meals.
研究组 & 干预措施
High fructose meal, with pyruvate label
2-13C pyruvate incorporated into a meal with high fructose content
干预措施: High fructose, pyruvate labeled meal (Other)
Low fructose meal, with fructose label
2-13C fructose incorporated into a meal with low fructose content
干预措施: Low fructose, fructose labeled meal (Other)
High fructose meal, with fructose label
2-13C fructose incorporated into a meal with high fructose content
干预措施: High fructose, fructose labeled meal (Other)
Low fructose meal, with pyruvate label
2-13C pyruvate incorporated into a meal with low fructose content
干预措施: Low fructose, pyruvate labeled meal (Other)
结局指标
主要结局
Hepatic fractional de novo lipogenesis in triglyceride rich lipoprotein (TRL)
时间窗: 6 hours
Measured by the detection of 13C carbons in TRL-palmitate from administered 13C labeled pyruvate or 13C labeled fructose.
Rate of appearance of UDP-glucose
时间窗: 6 hours
An estimate of hepatic glycogen flux measured by administration of D1 galactose and acetaminophen
Rate of appearance of blood glucose from gluconeogenesis
时间窗: 6 hours
Measured by the dilution method of labeled glucose
次要结局
- Serum glucose concentration(6 hours)
- Serum free fatty acid concentration(6 hours)
- Enteral (chylomicron) fractional de novo lipogenesis (DNL)(6 hours)
- Serum triglyceride concentration(6 hours)
- Serum lactate concentration(6 hours)
- Serum insulin concentration(6 hours)
- Hepatic (VLDL) fractional de novo lipogenesis (DNL)(6 hours)
- Extrasplanchnic fructose(6 hours)
- Whole body fructose oxidation(6 hours)