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Clinical Trial Details

Trial ID: L4428
Source ID: NCT01580813
Associated Drug: Acipimox
Title: Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes
Acronym: AcT2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01580813/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Acipimox|DRUG: Placebo
Outcome Measures: Primary: Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: VO2 Kinetics, Evaluate the impact of these effects of NEFA-lowering VO2 kinetics as measured by tau2, the time required for VO2 to reach 67% of peak during submaximal exercise., 7 to 9 days|Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak VO2, Evaluate the impact of these effects of NEFA-lowering on exercise capacity measured as peak VO2., 7 to 9 days | Secondary: Insulin Sensitivity, Test the hypothesis that lowering of endogenous non-essential fatty acids (NEFA) in diabetic adults will improve insulin sensitivity measured as glucose disposal by hyperinsulinemic euglycemic clamp. Unit of measure is mg/kg of lean body mass/min/microIU of insulin/ml. The unit of measure reflects the rate at which glucose needs to be infused to maintain a normal blood sugar in the setting of a given serum insulin level from an insulin infusion. As such, a higher number means more glucose was needed and indicates greater sensitivity to insulin., 7 to 9 days|Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Peak Heart Rate, Evaluate the impact of these effects of NEFA-lowering on exercise parameters, including VO2 kinetics, peak VO2, peak heart rate, peak power output., 7 to 9 days|Evaluate the Impact of Acipimox on Exercise Parameters in People With Type 2 Diabetes: Power Output at Anaerobic Threshold and at Peak Exercise, Evaluate the impact of these effects of NEFA-lowering on exercise parameters, including VO2 kinetics, peak VO2, peak heart rate, peak power output., 7 to 9 days|Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Inflammation, effect of lowering of endogenous non-essential fatty acids (NEFA) in diabetic adults on inflammation (hsCRP), 7 to 9 days|Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Endothelial Function, Test the hypothesis that lowering of endogenous non-essential fatty acids (NEFA) in diabetic adults will improve endothelial function measured by flow mediated dilation of the brachial artery., 7 to 9 days|Evaluating the Effect of Acipimox on Insulin Sensitivity and Cardiovascular Function: Cardiac Function, Test the hypothesis that lowering of endogenous non-essential fatty acids (NEFA) in diabetic adults will improve cardiac function: echo measurement of resting ejection fraction, 7 to 9 days|Triglycerides, 7 to 9 days
Sponsor/Collaborators: Sponsor: University of Colorado, Denver | Collaborators: US Department of Veterans Affairs|Pfizer
Gender: ALL
Age: ADULT
Phases:
Enrollment: 13
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-06
Completion Date: 2015-06-05
Results First Posted: 2021-12-03
Last Update Posted: 2021-12-03
Locations: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States
URL: https://clinicaltrials.gov/show/NCT01580813