Clinical trial NCT03189732: Effect of Metformin on Exercise-induced Lipolysis
Official title: New Electrophoretic Approaches in Studies of Obesity and Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: lipolysis
adipose tissue
exercise
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 10
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in adipose tissue lipolysis in response to exercise
timeFrame: Minute -60, 15, 30, 45, 60 and 120 from the start of exercise
Secondary outcomes:
measure: Change in lactate production in response to exercise
timeFrame: Minute -60, 15, 30, 45, 60 and 120 from the start of exercise
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Third Faculty of Medicine, Charles University
Study officials:
affiliation: Third faculty of medicine, Charles University in Prague
name: Vladimir Stich, prof
role: STUDY_CHAIR
References:
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.
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.
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.