Effect of Pharmacological Anti-lipolysis on FFA and VLDL-TG Metabolism Before and During Exercise
1 other identifier
interventional
9
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Apr 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedSeptember 18, 2012
September 1, 2012
1.4 years
December 13, 2010
September 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Acipimox
EXPERIMENTALTablet Acipimox 250 mg administered 4 times previous to and during the investigation day
Placebo
NO INTERVENTIONPlacebo tablets will be administered 4 times previous to and during the investigation day
Interventions
Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
Eligibility Criteria
You may qualify if:
- \- healthy, untrained males
You may not qualify if:
- medication
- history of malignancy, alcohol abuse or drug abuse
- participation in isotope trials in the last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital of Aarhus, Norrebrogade
Aarhus, Aarhus, 8000, Denmark
University Hospital of Aarhus, Norrebrogade
Aarhus, Aarhus, 8, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soren Nielsen, Dr. med.
University Hospital of Aarhus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD student
Study Record Dates
First Submitted
December 13, 2010
First Posted
December 15, 2010
Study Start
April 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
September 18, 2012
Record last verified: 2012-09