Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Lipolysis rate at rest, exercise and OGTT when blood lactate is elevated in MH individuals
研究概览
简要总结
The purpose of this study is to investigate whether the elevated circulating lactate levels of individuals with metabolic syndrome are responsible for their reduced lipolysis and glucose tolerance. The investigators will conduct an intervention study in which blood lactate levels will be elevated via intravenous infusion of sodium lactate. State of the art metabolic assessment using stable isotopes and indirect calorimetry will be used to study alterations in fat and carbohydrate metabolism.
详细描述
Individuals with metabolic syndrome and insulin resistance exhibit higher resting lactate concentrations than age-matched counterparts without metabolic disease. Recent studies suggest that lactate is not just a by-product of accelerated glycolysis but a signaling molecule that could even affect gene expression. However, the role of lactate in carbohydrate and fat metabolism at rest and during exercise remains incompletely described.
In this study, the investigators will elevate blood lactate levels in metabolically healthy individuals to levels observed in individuals with metabolic syndrome while measuring fat and carbohydrate metabolism in a fasted state, during exercise, and in response to an oral glucose load (oral glucose tolerance test).
10 metabolically healthy (MH) and 10 metabolically impaired (MI) individuals matched for sex and physical activity will participate in the study. MH will undergo two trials: one with intravenous lactate infusion and the other with isovolumetric saline infusion. The MI group will undergo only the saline trial.
Each trial consists of a 150 min basal period, an exercise period, followed by a 2-hour oral glucose tolerance test (OGTT). During the test, the investigators will:
Measure insulin sensitivity during the OGTT (Matsuda Index). Measure fat and carbohydrate oxidation using indirect calorimetry. Use stable isotope infusion to measure glycerol and glucose turnover rates in plasma using [1,1,2,3,3 2H]-glycerol and [6-6 2H], [U, 13C] - glucose.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •>18 years of age
- •Women non-pregnant or taking contraceptive medication
- •Physically active according to WHO's guidelines
- •Metabolic syndrome as IDF 2009 criteria (Alberti et al., Circulation)
- •Written and verbal consent to participation
排除标准
- •Chronic illness that prevents them from exercising
- •Affected blood samples at screening, as assessed by the PI
- •Assessed as unsuitable by PI
研究组 & 干预措施
Metabolically Healthy Individuals
Metabolically Healthy Individuals
干预措施: hyperlactacidemia (Other)
Metabolically Healthy Individuals
Metabolically Healthy Individuals
干预措施: Saline (0.9%, sterile, for infusion) (Other)
Metabolic Syndrome Individuals
Metabolic Syndrome Individuals
干预措施: Saline (0.9%, sterile, for infusion) (Other)
结局指标
主要结局
Lipolysis rate at rest, exercise and OGTT when blood lactate is elevated in MH individuals
时间窗: through study completion, an average of 2 years
Change in plasma \[1,1,2,3,3 D\] glycerol turnover rates
Effect of Na-Lactate on glucose tolerance to an oral load
时间窗: through study completion, an average of 2 years
Change in plasma \[6,6 D\]-glucose turnover rate
次要结局
- 13CO2 / 12CO2 in expired air(through study completion, an average of 2 years)
- Insulin sensitivity(through study completion, an average of 2 years)
- Indirect calorimetry(through study completion, an average of 2 years)
- Blood sample-insulin(through study completion, an average of 2 years)
- Blood samples - glucose(through study completion, an average of 2 years)
- Blood samples - Free fatty acids(through study completion, an average of 2 years)
- Blood samples - Glycerol(through study completion, an average of 2 years)
- Blood samples - Lactate(through study completion, an average of 2 years)
- Blood tracer/tracee ratio of 13C/12C glucose(through study completion, an average of 2 years)
- Blood tracer to tracee ratio of D2 glucose / unlabeled glucose(through study completion, an average of 2 years)
- Blood tracer to tracee ratio of D5 glycerol / unlabeled glycerol(through study completion, an average of 2 years)
研究者
Ricardo Mora
Head of the Exercise Physiology Laboratory at the University of Castilla-La Mancha
University of Castilla-La Mancha