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临床试验/NCT04710875
NCT04710875已完成不适用

The Role of Lactate in Lipolysis and Catabolism in Humans

University of Aarhus2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年3月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis

研究概览

简要总结

Lactate may have anti-lipolytic effects when plasma concentrations of lactate reach levels similar to those seen during high intensity exercise.

This study aims to investigate how lactate concentrations similar to those achieved during high intensity exercise affects lipolysis in humans. In addition to this, to investigate how increased lactate concentrations affects glucose- and amino acid metabolism.

8 healthy males will be included. Study participants will undergo two separate investigation days that will be identical except for the interventions:

  1. Intravenous sodium D/L-lactate
  2. Intravenous sodium chloride.

The study consists of a 3-hour basal period followed by a 3-hour hyperinsulinemic euglycemic clamp. During the study we will:

  • Estimate insulin sensitivity during the hyperinsulinemic euglycemic clamp (M value)
  • Use tracer kinetics to estimate lipid-, glucose and amino acid metabolism using [9,10-3H]-palmitate, [3-3H]-glucose, [15N]-phenylalanine, [15N]-tyrosine, [2H4]-tyrosine and [13C]-Urea.
  • Do muscle- and adipose tissue biopsies for analyses of signaling pathways involved in regulation of lipid-, glucose and amino acid metabolism.
  • Do blood samples of relevant hormones, metabolites and cytokines.
  • Use indirect calorimetry to estimate study participants' resting energy expenditure and respiratory quotient during the basal period.
  • Estimate cardiac ejection fraction by echocardiography and measure blood pressure during both the basal- and clamp period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • >18 years of age
  • BMI >19 and below 30
  • Written and verbal consent to participation

排除标准

  • Chronic illness
  • daily use of medicine
  • affected blood samples at screening, as assessed by the PI
  • does not speak and understand Danish
  • Assessed unsuitable by PI.

研究组 & 干预措施

Na-lactate

Active Comparator

Iv infusion of sodium D/L lactate

干预措施: Na-lactate (Drug)

Sodium chloride

Placebo Comparator

Iv infusion of Sodium chloride

干预措施: Sodium chloride (Drug)

结局指标

主要结局

Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis

时间窗: 2 hours (1 hour basal period, 1 hour clamp)

Change in \[9,10-3H\]-palmitate tracer flux

次要结局

  • Blood samples - Insulin(6 hours.)
  • Acute Metabolic effects of Na-lactate compared with NaCl on glucose metabolism(6 hours (3 hours basal period, 3 hours clamp))
  • Indirect calorimetry during clamp(20 minutes)
  • Insulin sensitivity(3 hours.)
  • Acute metabolic effects of Na-lactate compared with NaCl on aminoacid metabolism(6 hours)
  • Indirect calorimetry during basal conditions(20 minutes)
  • Echocardiography(15 minutes)
  • blood pressure(2 x 10 min)
  • Blood samples - cortisol(6 hours.)
  • Blood samples - GDF-15(6 hours.)
  • Blood samples - glucagon(6 hours.)
  • Blood samples - glucose(6 hours.)
  • Blood samples - c-peptid(6 hours.)
  • Blood samples - Ghrelin(6 hours.)
  • Blood samples - free fatte acids(6 hours.)
  • Blood samples - lactate(6 hours.)
  • Changes in signaling in muscle tissue between interventions(After 3 and 5 hours of intervention)
  • Changes in signaling in adipose tissue between interventions(After 3 and 5 hours of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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