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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01260376
First Posted: December 15, 2010
Last Update Posted: September 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Birgitte Nellemann, University of Aarhus
  Purpose
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
Diabetes Obesity Drug: Acipimox

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 Birgitte Nellemann, University of Aarhus:

Primary Outcome Measures:
  • Effects of exercise and antilipolysis on FFA and VLDL-TG kinetics [ Time Frame: 6 hour investigation day ]
    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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260376


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

Responsible Party: Birgitte Nellemann, MD PhD student, University of Aarhus
ClinicalTrials.gov Identifier: NCT01260376     History of Changes
Other Study ID Numbers: M-20100221
First Submitted: December 13, 2010
First Posted: December 15, 2010
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by Birgitte Nellemann, University of Aarhus:
VLDL-TG
Metabolism
Exercise
Free Fatty Acids

Additional relevant MeSH terms:
Acipimox
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents