Effect of Metformin on Exercise-induced Lipolysis

February 12, 2020 updated by: Vladimir Stich, Charles University, Czech Republic

New Electrophoretic Approaches in Studies of Obesity and Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 100 00
        • Third Faculty of Medicine, Charles University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin oral +exercise
Metformin, one dose 2000mg, 2.5h before the start of 60 min physical exercise
Other: Exercise
Other Names:
  • Acute exercise
Drug: Metformin Oral
Other Names:
  • Metformin tablet
Active Comparator: Metformin local in AT +exercise
Metformin perfused into microdialysis probe inserted in adipose tissue, 0.3ug/min 1.5h before the exercise and during 60min physical exercise
Other: Exercise
Other Names:
  • Acute exercise
Drug: Metformin local in AT
Other Names:
  • Metformin dialysate
Active Comparator: No metformin + exercise
60min physical exercise without pretreatment of metformin
Other: Exercise
Other Names:
  • Acute exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Minute -60, 15, 30, 45, 60 and 120 from the start of exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Minute -60, 15, 30, 45, 60 and 120 from the start of exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Study Chair: Vladimir Stich, prof, Third faculty of medicine, Charles University in Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

August 30, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-03139S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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