NCT01488409|CompletedPhase 2ResultsDMC
Effects of Acipimox on Mitochondrial Function in Obesity
The Effects of Short Term Acipimox Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity
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Sponsor study identifier
interventional
39
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)The purpose of the study is to examine whether a medication called acipimox can improve your body's mitochondria. Mitochondria are the "power house" of the cell and make energy for your body. Obesity is associated with increased risk for developing diabetes. However, the investigators do not know how obesity leads to diabetes. Previous studies have shown levels of fat in the blood (free fatty acids or FFA) are higher in obesity, and elevated FFA can affect how our body uses glucose and responds to insulin. Recent studies have shown that changes in mitochondria may be involved in the development of diabetes and may be affected by FFA. The investigators propose to improve the function of mitochondria in obese people with pre-diabetes by treating with acipimox, a medication which decreases FFA. The investigators will use state of the art techniques to evaluate the mitochondria, including a new magnetic resonance imaging (MRI) technique to measure function of mitochondria in muscle.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2011
Actual (reported)December 8, 2011
Actual (reported)May 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 2015
Actual (reported)January 2015
Actual (reported)February 3, 2016
Actual (reported)Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months
The rate of recovery of phosphocreatine concentration after depletion by exercise is considered a measurement of mitochondrial function. Change in phosphocreatine recovery from baseline to 6 months will therefore give a measurement of change in mitochondrial function. ViPCR is given -- a higher value indicates better mitochondrial function.
Change from Baseline to 6-months Visit
Change From Baseline in Insulin Sensitivity at 6-months
Change from Baseline to 6-months visit
Change From Baseline in Mitochondrial Density at 6 Months
Change from Baseline to 6-months
Change From Baseline in Intramyocellular Lipid Content at 6-months
Change from Baseline to 6-months
Change From Baseline in Lipid Profile at 6-months
Change from Baseline to 6-months
Treatment with the study drug Acipimox
Treatment with Placebo control.
250 mg by mouth (PO) three times daily
0 mg by mouth (PO) three times daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Makimura H, Stanley TL, Suresh C, De Sousa-Coelho AL, Frontera WR, Syu S, Braun LR, Looby SE, Feldpausch MN, Torriani M, Lee H, Patti ME, Grinspoon SK. Metabolic Effects of Long-Term Reduction in Free Fatty Acids With Acipimox in Obesity: A Randomized Trial. J Clin Endocrinol Metab. 2016 Mar;101(3):1123-33. doi: 10.1210/jc.2015-3696. Epub 2015 Dec 21.
Steven Grinspoon, MD
Massachusetts General Hospital
39 participants (actual enrollment reported by the registry).
First Submitted
December 2, 2011
First Posted
December 8, 2011
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes
Contact the study team to confirm eligibility.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
March 1, 2016
Results First Posted
February 3, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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