Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes (AcT2)
People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of certain fats in their blood. The blood vessels and heart of most of these individuals do not work normally and people with T2DM also have an impaired ability to perform exercise. The purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily decrease the level of fat in the bloodstream of people with T2DM and observe the physiological changes to blood vessel function and exercise capacity and insulin sensitivity. This will help us to understand ways of improving blood vessel function and the ability to exercise effectively in people who are overweight or have T2DM.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effects of Serum Fatty Acid Lowering on Insulin Sensitivity, Cardiovascular Function, And Exercise Capacity in Non-Insulin Dependent Diabetes|
- Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function [ Time Frame: 2 years ] [ Designated as safety issue: No ]Test the hypothesis that lowering of endogenous NEFA in diabetic adults will improve insulin sensitivity, inflammation, and endothelial and cardiac function
- Evaluate the Impact of Acipimox on Exercise Parameters in People with Type 2 Diabetes [ Time Frame: 2 years ] [ Designated as safety issue: No ]Evaluate the impact of these effects of NEFA-lowering on exercise parameters, including VO2 kinetics, peak VO2, peak heart rate, peak power output, and peak exercise cardiac function
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
Other Name: Olbetam
|Placebo Comparator: Placebo||
Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580813
|Contact: Leah Herlache, MSemail@example.com|
|United States, Colorado|
|University of Colorado Anschutz Medical Campus||Recruiting|
|Aurora, Colorado, United States, 80045|
|Principal Investigator: Irene Schauer, MD, PhD|
|Principal Investigator:||Irene Schauer, MD, PhD||University of Colorado, Denver|