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临床试验/NCT03189732
NCT03189732已完成不适用

New Electrophoretic Approaches in Studies of Obesity and Diabetes

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年10月1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
发起方
入组人数
10
试验地点
1
主要终点
Change in adipose tissue lipolysis in response to exercise

研究概览

简要总结

The aim of this study is to investigate whether metformin has inhibitory effect on exercise-induced lipolysis in subcutaneous adipose tissue in healthy lean man. Ten healthy lean mean will follow protocols consisting of 60 minutes of exercise on bicycle ergometer combined with a) orally administered metformin and b) locally administered metformin into adipose tissue and c) without metformin treatment. Microdialysis is used for assessment of metabolites in situ in subcutaneous adipose tissue.

详细描述

Metformin and physical activity are often recommended as the first therapeutic agents to improve glycemic control for prediabetes and type 2 diabetes (ADA). It has been reported that metformin decrease plasma concentration of non-esterified fatty acids in patients with type 2 diabetes which might be associated with the inhibition of lipolysis in adipose tissue. However, the inhibition of lipolysis during physical exercise, would not be probably beneficial. Thus, the effect of metformin on lipolysis during exercise is investigated in this protocol. As the lipolysis regulation is often impaired in obese and diabetic patients, the healthy lean men were chosen for this pilot study. Glycerol will be analyzed as a measure of lipolytic rate in adipose tissue and in plasma. Lactate levels will be observed. Our findings should provide a new background about the combination of physical activity and metformin medication.

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
None

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy lean men, non obese, BMI 20-28 kg/m2

排除标准

  • weight change within the 3 months before the study,
  • hypertension,
  • impaired fasting glucose
  • hyperlipidemia
  • drug or alcohol abuse

研究组 & 干预措施

Metformin oral +exercise

Experimental

Metformin, one dose 2000mg, 2.5h before the start of 60 min physical exercise

干预措施: Metformin Oral (Drug)

Metformin oral +exercise

Experimental

Metformin, one dose 2000mg, 2.5h before the start of 60 min physical exercise

干预措施: Exercise (Other)

Metformin local in AT +exercise

Active Comparator

Metformin perfused into microdialysis probe inserted in adipose tissue, 0.3ug/min 1.5h before the exercise and during 60min physical exercise

干预措施: Metformin local in AT (Drug)

Metformin local in AT +exercise

Active Comparator

Metformin perfused into microdialysis probe inserted in adipose tissue, 0.3ug/min 1.5h before the exercise and during 60min physical exercise

干预措施: Exercise (Other)

No metformin + exercise

Active Comparator

60min physical exercise without pretreatment of metformin

干预措施: Exercise (Other)

结局指标

主要结局

Change in adipose tissue lipolysis in response to exercise

时间窗: Minute -60, 15, 30, 45, 60 and 120 from the start of exercise

Glycerol concentration in dialysate outcoming from adipose tissue and in plasma - kinetic study

次要结局

  • Change in lactate production in response to exercise(Minute -60, 15, 30, 45, 60 and 120 from the start of exercise)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vladimir Stich

Professor, MUDr

Charles University, Czech Republic

研究点 (1)

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