Effect of Metformin on Exercise-induced Lipolysis

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

New Electrophoretic Approaches in Studies of Obesity and Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189732
• Other study ID #: 15-03139S
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: January 2018

Study information

• Verified date: February 2020
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2018
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Metformin Oral

• Metformin local in AT

Other:
• Exercise

Locations

Country	Name	City	State
Czechia	Third Faculty of Medicine, Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

Bourron O, Daval M, Hainault I, Hajduch E, Servant JM, Gautier JF, Ferré 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in lactate production in response to exercise	Concentration of lactate in dialysate and in plasma - kinetic study	Minute -60, 15, 30, 45, 60 and 120 from the start of exercise