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NCT02819440 · ClinicalTrials.gov registry record · Phase 2
PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction
A Phase 2 study of Healthy and Obese, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
- 1
- Study location
NCT02819440: Completed Phase 2 study of Healthy and Obese, sponsored by Vanderbilt University Medical Center.
NCT02819440 is a Phase 2 study of Healthy and Obese that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 141 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02819440, a Phase 2 study of Healthy and Obese, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
- 1
- Study location
Study Summary
Obesity and its adverse cardiometabolic consequences are major public health problems. Several features of obesity contribute to the associated cardiovascular risk and are potential targets for intervention. These include insulin resistance and beta cell dysfunction, reduced metabolic rate, and impaired aerobic capacity.The purpose of this study is to examine if the phosphodiesterase type 5A inhibitor tadalafil improves cardiometabolic health in individuals who are obese and insulin resistant.
Primary Outcome
Subjects will undergo a metabolic chamber protocol to measure resting exercise energy expenditure (kcal/min) at 12 weeks adjusted statistically for the baseline measurement.
Interventions
- DRUG Placebo
- DRUG Tadalafil
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2016-07 |
| Est. Completion | 2020-06 |
| Phase | Phase 2 |
What the finished NCT02819440 record still lists
NCT02819440 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02819440 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02819440 about?
NCT02819440 is a clinical study titled "PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction". Obesity and its adverse cardiometabolic consequences are major public health problems. Several features of obesity contribute to the associated cardiovascular risk and are potential targets for intervention. These include insulin resistance and beta cell dysfunction, reduced metabolic rate, and impa...
What is the current status of trial NCT02819440?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2016-07. Estimated completion is 2020-06.
What conditions does trial NCT02819440 study?
This clinical trial studies the following conditions: Healthy, Obese.
What interventions are being tested in trial NCT02819440?
The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT02819440?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02819440 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02819440's enrollment target sits among peer trials
141 164th of 1090 higher than 927 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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