NCT03189732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

May 31, 2017

Last Update Submit

February 12, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

lipolysisadipose tissueexercise

Outcome Measures

Primary Outcomes (1)

  • Change in adipose tissue lipolysis in response to 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 Outcomes (1)

  • Change in lactate production in response to exercise

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

Study Arms (3)

Metformin oral +exercise

EXPERIMENTAL

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

Drug: Metformin OralOther: Exercise

Metformin local in AT +exercise

ACTIVE COMPARATOR

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

Drug: Metformin local in ATOther: Exercise

No metformin + exercise

ACTIVE COMPARATOR

60min physical exercise without pretreatment of metformin

Other: Exercise

Interventions

Metformin OralDRUG
Also known as: Metformin tablet
Metformin oral +exercise
Metformin local in ATDRUG
Also known as: Metformin dialysate
Metformin local in AT +exercise
ExerciseOTHER
Also known as: Acute exercise
Metformin local in AT +exerciseMetformin oral +exerciseNo metformin + exercise

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Faculty of Medicine, Charles University

Prague, 100 00, Czechia

Location

Related Publications (3)

  • 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.

    PMID: 20043143BACKGROUND

  • 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.

    PMID: 10656228BACKGROUND

  • 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.

    PMID: 16901933BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Interventions

MetforminExercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Vladimir Stich, prof

    Third faculty of medicine, Charles University in Prague

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MUDr

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 16, 2017

Study Start

October 1, 2015

Primary Completion

August 30, 2017

Study Completion

January 1, 2018

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)