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NCT01410487 · ClinicalTrials.gov registry record
Effects of Weight Loss on Cardio-respiratory Function
A clinical trial of Obesity and Cardiovascular Abnormalities, sponsored by NYU Langone Health.
- Completed
- Registry status
- 150
- Enrollment target
- 1
- Study location
NCT01410487: Completed study of Obesity and Cardiovascular Abnormalities, sponsored by NYU Langone Health.
NCT01410487 is a study of Obesity and Cardiovascular Abnormalities that has completed, run by NYU Langone Health. The registered enrollment target is 150 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01410487, a study of Obesity and Cardiovascular Abnormalities, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
Obesity is a medical problem of epidemic proportions and is associated with high mortality. Obesity has significant effects on the cardiovascular system, producing structural cardiovascular changes including myocardial hypertrophy, fatty infiltration, and fibrosis; diastolic and systolic dysfunction; changes in pulmonary artery compliance; and increased aortic stiffness - all of which can lead to heart failure. Indeed, evidence suggests that obesity increases the risk for heart disease independent of other known risk factors such as coronary artery disease, hypertension, diabetes mellitus, and obstructive sleep apnea. Obesity also causes significant changes in pulmonary function, including a decrease in expiratory reserve volume and functional residual capacity and closure of peripheral airways. The exact mechanisms for the development of cardiopulmonary disease are not well understood - the pathophysiology is complex and likely multifactorial, related to altered hemodynamic load, altered metabolic activity, underlying inflammation, and increased cardiac output. Newer diagnostic modalities available at our institution such as cardiac MRI and pulmonary function tests with impulse oscillometry allow us to better evaluate cardiopulmonary dysfunction in patients with severe obesity. Cardiac MRI is especially promising as a non-invasive imaging modality in obese individuals, providing more reproducible measurements of cardiac and vascular anatomy and function relative to echocardiography. Similarly, pulmonary function testing with impulse oscillometry is more sensitive for detection of abnormalities in the distal airways especially when spirometry is normal, as frequently occurs in the severely obese symptomatic patients. The main objective of the proposed study is to evaluate the effect of obesity on quality of life and health care utilization and its relationship to cardiopulmonary disease in an ethnically diverse, underserved obese population by using state-of-the-ar
Primary Outcome
Detailed evaluation of quality of life, health care utilization and the cardiopulmonary system in severe obesity, with an assessment of the correlation between specific cardiovascular and pulmonary parameters to improve our understanding and treatment of symptomatic obese patients.
Conditions Studied
Study Locations (1)
New York
- Bellevue Hospital Ambulatory Cinic - Suite 1D - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-12 |
What the finished NCT01410487 record still lists
NCT01410487 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 0 interventions.
NCT01410487 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01410487 about?
NCT01410487 is a clinical study titled "Effects of Weight Loss on Cardio-respiratory Function". Obesity is a medical problem of epidemic proportions and is associated with high mortality. Obesity has significant effects on the cardiovascular system, producing structural cardiovascular changes including myocardial hypertrophy, fatty infiltration, and fibrosis; diastolic and systolic dysfunction...
What is the current status of trial NCT01410487?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2011-09. Estimated completion is 2013-12.
What conditions does trial NCT01410487 study?
This clinical trial studies the following conditions: Obesity, Cardiovascular Abnormalities.
Who is sponsoring clinical trial NCT01410487?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01410487 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
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 NCT01410487's enrollment target sits among peer trials
150 370th of 1053 higher than 668 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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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