Effects of Acipimox on Mitochondrial Function in Obesity
|ClinicalTrials.gov Identifier: NCT01488409|
Recruitment Status : Completed
First Posted : December 8, 2011
Results First Posted : February 3, 2016
Last Update Posted : March 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Obesity Insulin Resistance Hypertriglyceridemia||Drug: Acipimox Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Short Term Acipimox Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity|
|Study Start Date :||May 2012|
|Primary Completion Date :||January 2015|
|Study Completion Date :||January 2015|
Treatment with the study drug Acipimox
250 mg by mouth (PO) three times daily
Placebo Comparator: Placebo
Treatment with Placebo control.
0 mg by mouth (PO) three times daily
- Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months [ Time Frame: Change from Baseline to 6-months Visit ]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 in Insulin Sensitivity at 6-months [ Time Frame: Change from Baseline to 6-months visit ]Change in insulin resistance assessed by hyperinsulinemic-euglycemic clamp study at Baseline and at 6-months. Change in insulin-stimulated glucose uptake (M) during 40 mU/m2/min insulin clamp is given.
- Change From Baseline in Mitochondrial Density at 6 Months [ Time Frame: Change from Baseline to 6-months ]Muscle tissue obtained from biopsy will be used to assess mitochondrial number and morphology by microscopes at Baseline and at 6-months. The change in mitochondrial density from 6 months to baseline is given.
- Change From Baseline in Intramyocellular Lipid Content at 6-months [ Time Frame: Change from Baseline to 6-months ]Change in tibialis intramyocellular lipid (IMCL) normalized to creatinine is given.
- Change From Baseline in Lipid Profile at 6-months [ Time Frame: Change from Baseline to 6-months ]Change in direct low density lipoprotein (LDL) cholesterol is given
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488409
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Steven Grinspoon, MD||Massachusetts General Hospital|