Effect of Metformin on Exercise-induced Lipolysis

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Metformin local in AT; Drug: Metformin Oral; Other: Exercise

• Registration Number: NCT03189732
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Primary Completion: 2017-08-30
• Study Completion: 2018-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin local in AT +exercise	Metformin local in AT	Metformin perfused into microdialysis probe inserted in adipose tissue, 0.3ug/min 1.5h before the exercise and during 60min physical exercise
Metformin oral +exercise	Exercise	Metformin, one dose 2000mg, 2.5h before the start of 60 min physical exercise
Metformin local in AT +exercise	Exercise	Metformin perfused into microdialysis probe inserted in adipose tissue, 0.3ug/min 1.5h before the exercise and during 60min physical exercise
Metformin oral +exercise	Metformin Oral	Metformin, one dose 2000mg, 2.5h before the start of 60 min physical exercise
No metformin + exercise	Exercise	60min physical exercise without pretreatment of metformin

Primary Outcome Measures

Name	Time	Method
Change in adipose tissue lipolysis in response to exercise	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 Outcome Measures

Name	Time	Method
Change in lactate production in response to exercise	Minute -60, 15, 30, 45, 60 and 120 from the start of exercise	Concentration of lactate in dialysate and in plasma - kinetic study

Trial Locations

Locations (1)

Third Faculty of Medicine, Charles University; 🇨🇿 Prague, Czechia