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

This study has been completed.
Information provided by (Responsible Party):
Birgitte Nellemann, University of Aarhus Identifier:
First received: December 13, 2010
Last updated: September 17, 2012
Last verified: September 2012

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.

Condition Intervention
Drug: Acipimox

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Pharmacological Anti-lipolysis on FFA and VLDL-TG Metabolism Before and During Exercise

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Effects of exercise and antilipolysis on FFA and VLDL-TG kinetics [ Time Frame: 6 hour investigation day ] [ Designated as safety issue: No ]
    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.

Enrollment: 9
Study Start Date: April 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acipimox
Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
Drug: Acipimox
Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
No Intervention: Placebo
Placebo tablets will be administered 4 times previous to and during the investigation day

Detailed 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.


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01260376

University Hospital of Aarhus, Norrebrogade
Aarhus, Denmark, 8
University Hospital of Aarhus, Norrebrogade
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Soren Nielsen, Dr. med. University Hospital of Aarhus
  More Information

No publications provided

Responsible Party: Birgitte Nellemann, MD PhD student, University of Aarhus Identifier: NCT01260376     History of Changes
Other Study ID Numbers: M-20100221
Study First Received: December 13, 2010
Last Updated: September 17, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Free Fatty Acids

Additional relevant MeSH terms:
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 25, 2015