Effect of Metformin on Exercise-induced Lipolysis

NCT ID: NCT03189732

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Metformin oral +exercise

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

Group Type EXPERIMENTAL

Metformin Oral

Intervention Type DRUG

Exercise

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Metformin local in AT

Intervention Type DRUG

Exercise

Intervention Type OTHER

No metformin + exercise

60min physical exercise without pretreatment of metformin

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Interventions

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Metformin Oral

Intervention Type DRUG

Metformin local in AT

Intervention Type DRUG

Exercise

Intervention Type OTHER

Other Intervention Names

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Metformin tablet Metformin dialysate Acute exercise

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Vladimir Stich

Professor, MUDr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vladimir Stich, prof

Role: STUDY_CHAIR

Third faculty of medicine, Charles University in Prague

Locations

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Third Faculty of Medicine, Charles University

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 20043143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10656228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16901933 (View on PubMed)

Other Identifiers

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15-03139S

Identifier Type: -

Identifier Source: org_study_id

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