Effect of Pharmacological Anti-lipolysis on FFA and VLDL-TG Metabolism Before and During Exercise

Obesity Clinical Trial

Official title:

Effect of Pharmacological Anti-lipolysis on FFA and VLDL-TG Metabolism Before and During Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260376
• Other study ID #: M-20100221
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: September 17, 2012
• Start date: April 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

This study will investigate free fatty acid and VLDL-TG metabolism before and during exercise with and without pharmacological antilipolysis by the niacin antagonist Acipimox. Main focuses will be VLDL-TG and free fatty acid metabolism as well as expression of membrane proteins in fat- and muscle biopsies.

Description:

Insulin resistance in liver and skeletal muscle is of central pathogenic significance in the development of type 2 diabetes. The molecular connections are unresolved but high levels of free fatty acids and triglyceride is probably involved. Diabetic subjects and to a lesser extent obese subjects have increased triglyceride levels, this could be due to an abnormal turnover of VLDL-TG. It is not yet investigated whether VLDL-TG kinetics changes during pharmacological antilipolysis. Using the aseptic ex-vivo labeling technique (developed in our laboratories) we will investigate this issue in sedentary healthy men. After a 3 hour basal period subjects will exercise on a bike for 60 minutes at 60% of VO2max. In both basal and exercise period one muscle and one fat biopsy will be obtained, further blood samples will be drawn to examine FFA and VLDL-TG metabolism etc..

This new knowledge will contribute to the understanding of metabolic disorders like type 2 diabetes and obesity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• healthy, untrained males

Exclusion Criteria:

• medication

• history of malignancy, alcohol abuse or drug abuse

• participation in isotope trials in the last 6 months

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Drug:
• Acipimox
Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day

Locations

Country	Name	City	State
Denmark	University Hospital of Aarhus, Norrebrogade	Aarhus
Denmark	University Hospital of Aarhus, Norrebrogade	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of exercise and antilipolysis on FFA and VLDL-TG kinetics	Healthy untrained men, investigated with pharmacological antilipolysis by Acipimox (Olbetam) and placebo on 2 occasions. Each day consists of 3 hour basal period and 90 minutes exercise on a bicycle at 60% of VO2-maximum. During the day glucose and lipid metabolism is investigated by glucose and VLDL tracer, as well as indirect calorimetrics. Cellular signaling is investigated by 2 muscle- and 2 fat biopsies each day.	6 hour investigation day	No