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Completed

NCT Number: NCT03189732

Effect of Metformin on Exercise-induced Lipolysis

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Third Faculty of Medicine, Charles University

Prague, 100 00, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Metformin Oral

Drug

Other names: Metformin tablet

Metformin local in AT

Drug

Other names: Metformin dialysate

Exercise

Other

Other names: Acute exercise

Primary outcomes

  1. Change in adipose tissue lipolysis in response to exercise

    Time frame: 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

Secondary outcomes

  1. Change in lactate production in response to exercise

    Time frame: Minute -60, 15, 30, 45, 60 and 120 from the start of exercise

    Concentration of lactate in dialysate and in plasma - kinetic study

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

New Electrophoretic Approaches in Studies of Obesity and Diabetes

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 16, 2017
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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