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Effect of Metformin on Exercise-induced Lipolysis

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Metformin Oral
Metformin local in AT
Exercise
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring lipolysis, adipose tissue, exercise

Eligibility Criteria

25 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Third Faculty of Medicine, Charles University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Metformin oral +exercise

Metformin local in AT +exercise

No metformin + exercise

Arm Description

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

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

60min physical exercise without pretreatment of metformin

Outcomes

Primary Outcome Measures

Change in adipose tissue lipolysis in response to exercise
Glycerol concentration in dialysate outcoming from adipose tissue and in plasma - kinetic study

Secondary Outcome Measures

Change in lactate production in response to exercise
Concentration of lactate in dialysate and in plasma - kinetic study

Full Information

First Posted
May 31, 2017
Last Updated
February 12, 2020
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT03189732
Brief Title
Effect of Metformin on Exercise-induced Lipolysis
Official Title
New Electrophoretic Approaches in Studies of Obesity and Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
lipolysis, adipose tissue, exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin oral +exercise
Arm Type
Experimental
Arm Description
Metformin, one dose 2000mg, 2.5h before the start of 60 min physical exercise
Arm Title
Metformin local in AT +exercise
Arm Type
Active Comparator
Arm Description
Metformin perfused into microdialysis probe inserted in adipose tissue, 0.3ug/min 1.5h before the exercise and during 60min physical exercise
Arm Title
No metformin + exercise
Arm Type
Active Comparator
Arm Description
60min physical exercise without pretreatment of metformin
Intervention Type
Drug
Intervention Name(s)
Metformin Oral
Other Intervention Name(s)
Metformin tablet
Intervention Type
Drug
Intervention Name(s)
Metformin local in AT
Other Intervention Name(s)
Metformin dialysate
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Acute exercise
Primary Outcome Measure Information:
Title
Change in adipose tissue lipolysis in response to exercise
Description
Glycerol concentration in dialysate outcoming from adipose tissue and in plasma - kinetic study
Time Frame
Minute -60, 15, 30, 45, 60 and 120 from the start of exercise
Secondary Outcome Measure Information:
Title
Change in lactate production in response to exercise
Description
Concentration of lactate in dialysate and in plasma - kinetic study
Time Frame
Minute -60, 15, 30, 45, 60 and 120 from the start of exercise

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Stich, prof
Organizational Affiliation
Third faculty of medicine, Charles University in Prague
Official's Role
Study Chair
Facility Information:
Facility Name
Third Faculty of Medicine, Charles University
City
Prague
ZIP/Postal Code
100 00
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20043143
Citation
Bourron O, Daval M, Hainault I, Hajduch E, Servant JM, Gautier JF, Ferre P, Foufelle F. Biguanides and thiazolidinediones inhibit stimulated lipolysis in human adipocytes through activation of AMP-activated protein kinase. Diabetologia. 2010 Apr;53(4):768-78. doi: 10.1007/s00125-009-1639-6. Epub 2009 Dec 31.
Results Reference
background
PubMed Identifier
10656228
Citation
Flechtner-Mors M, Ditschuneit HH, Jenkinson CP, Alt A, Adler G. Metformin inhibits catecholamine-stimulated lipolysis in obese, hyperinsulinemic, hypertensive subjects in subcutaneous adipose tissue: an in situ microdialysis study. Diabet Med. 1999 Dec;16(12):1000-6. doi: 10.1046/j.1464-5491.1999.00189.x.
Results Reference
background
PubMed Identifier
16901933
Citation
Ren T, He J, Jiang H, Zu L, Pu S, Guo X, Xu G. Metformin reduces lipolysis in primary rat adipocytes stimulated by tumor necrosis factor-alpha or isoproterenol. J Mol Endocrinol. 2006 Aug;37(1):175-83. doi: 10.1677/jme.1.02061.
Results Reference
background

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Effect of Metformin on Exercise-induced Lipolysis

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