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Clinical Trial Details

Trial ID: L5197
Source ID: NCT01364584
Associated Drug: Exenatide
Title: Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes
Acronym: Exenatide
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01364584/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Exenatide|DRUG: Placebo
Outcome Measures: Primary: Peak Oxygen Consumption (VO2 Peak), Subjects' peak oxygen consumption (VO2 peak) will be tested on a stationary bike before and after 3 months of study medication or placebo., Baseline and 3 months | Secondary: Oxygen Uptake Kinetics Steady State Tau, Time to steady state oxygen consumption will be assessed in subject before and after 3 months of study medication or placebo., Baseline and 3 months|Change From Baseline in Arterial Stiffness, Pulse wave velocity will be measured via sphygmocor before and after 3 months of study medication or placebo., Baseline and 3 months|Change From Baseline in Peak Dilation of Brachial Artery Diameter, Change in the response of the brachial artery to hyperemia will be assessed before and after 3 months of study medication or placebo., Baseline and 3 months|Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise, Deoxygenated hemoglobin concentration will be measured using near-infrared spectroscopy during sub-maximal exercise before and after 3 months of study drug administration., Baseline and 3 months|Echocardiographic Measures - Circumferential Strain, Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo., Baseline and 3 months|Echocardiographic Measures - Longitudinal Strain, Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo., Baseline and 3 months|Echocardiographic Measures - Stroke Volume, Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo., Baseline and 3 months|Echocardiographic Measures - Mitral Valve E Wave Velocity, Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo., Baseline and 3 months|Echocardiographic Measures - Mitral Valve E:A Wave Velocity, Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo., Baseline and 3 months|Echocardiographic Measures - Mitral Valve Deceleration Time, Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo., Baseline and 3 months|Echocardiographic Measures - Septal E', Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo., Baseline and 3 months|Echocardiographic Measures - Septal E:E', Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo., Baseline and 3 months|Echocardiographic Measures - Lateral E', Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo., Baseline and 3 months|Echocardiographic Measures - Lateral E:E', Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo., Baseline and 3 months
Sponsor/Collaborators: Sponsor: University of Colorado, Denver | Collaborators: Amylin Pharmaceuticals, LLC.|Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 23
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2010-10
Completion Date: 2014-12
Results First Posted: 2018-07-09
Last Update Posted: 2023-07-12
Locations: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States
URL: https://clinicaltrials.gov/show/NCT01364584