| Trial ID: | L3356 |
| Source ID: | NCT01951339
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| Associated Drug: |
Sitagliptin
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| Title: |
Impact of Sitagliptin on Cardiovascular Exercise Performance in Type 2 Diabetes
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01951339/results
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| Conditions: |
Type 2 Diabetes|Cardiovascular Disease
|
| Interventions: |
DRUG: Sitagliptin|DRUG: Glimepiride|DRUG: Placebo|DRUG: Placebo
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| Outcome Measures: |
Primary: Peak Oxygen Consumption (VO2peak)., Subjects' peak oxygen consumption will be tested on a stationary bike before and after 3 months of study medication., Pre-intervention (Baseline) and post-intervention (3 months)|Changes From Baseline in 31P Measurement: Phosphocreatine Time Constant, Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment, Pre-intervention (Baseline) and post-intervention (3 months)|Change in Oxygen Uptake Kinetics (VO2 Kinetics), Oxygen uptake kinetics will be tested on a stationary bike before and after 3 months of study medication. VO2 kinetics is reported as the time constant associated with the change in oxygen update from rest to steady state., Pre-intervention (Baseline) and post-intervention (3 months)|Changes From Baseline in 31P Measurement: Free Pi Time Constant, Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment. Data are represented as the change in Pi through the scan., Pre-intervention (Baseline) and post-intervention (3 months)|Changes From Baseline in 31P Measurement: Adenosine Triphosphate (ATP) Peaks, Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment, Pre-intervention (Baseline) and post-intervention (3 months)|Changes From Baseline in 31P Measurement: Adenosine Diphosphate (ADP) Time Constant, Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment, Pre-intervention (Baseline) and post-intervention (3 months)|Changes From Baseline in 31P Measurement: pH, Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment, Pre-intervention (Baseline) and post-intervention (3 months) | Secondary: Changes From Baseline in Echocardiographic Measures (Stroke Volume), Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication, Pre-intervention (Baseline) and post-intervention (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., Pre-intervention (Baseline) and post-intervention (3 months)
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| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver | Collaborators: Merck Sharp & Dohme LLC
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2013-10
|
| Completion Date: |
2018-06
|
| Results First Posted: |
2019-05-22
|
| Last Update Posted: |
2023-07-12
|
| Locations: |
University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01951339
|
