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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:
Information provided by (Responsible Party):
Birgitte Nellemann, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01260376
First received: December 13, 2010
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  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 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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260376

Locations
Denmark
University Hospital of Aarhus, Norrebrogade
Aarhus, Denmark, 8
University Hospital of Aarhus, Norrebrogade
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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
ClinicalTrials.gov 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:
VLDL-TG
Metabolism
Exercise
Free Fatty Acids

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Acipimox
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013