ObesityNCT01410487
Effects of Weight Loss on Cardio-respiratory Function
An observational study of Obesity and Cardiovascular Abnormalities, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity, Cardiovascular Abnormalities
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients utilizing the Bariatric Clinic services at Bellevue (City/Public) Hospital.
Who may be able to join
- Eligible patients for this study are patients who are booked for bariatric surgery and who have cardiopulmonary symptoms that require further cardiopulmonary testing prior to bariatric surgery.
Who cannot join
- Patients with contraindications to MRI examination with gadolinium contrast and adenosine administration will be excluded. Additional exclusions include being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks), participation in other obesity- or diabetes-related clinical trials, or diagnosis of cognitive dysfunction or significant psychiatric comorbidity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bellevue Hospital Ambulatory Cinic - Suite 1D
New York, New York, 10016
About this study
Official title: Effects of Weight Loss on Cardio-respiratory Function and Patient-centered Outcomes in an Underserved, Minority Population With Clinically Severe Obesity
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-art diagnostic modalities before and after significant (20%) weight loss.
Read more
The investigators propose to perform stress cardiac MRI and pulmonary function testing with oscillometry before and after significant surgical weight loss in 150 severely obese patients with cardiopulmonary symptoms. Patients evaluated in the comprehensive Obesity Center at Bellevue Hospital who meet NIH Consensus Guidelines for Bariatric Surgery, who have cardiopulmonary symptoms, and who meet clinical criteria for cardiac stress testing and pulmonary function testing will be approached by the study personnel and offered enrollment. Informed consent will be obtained. Enrolled patients will undergo clinical evaluation with a detailed medical history including the Borg dyspnea scale, physical examination, laboratory testing including cardiopulmonary biomarkers (brain natriuretic peptide, C-reactive protein, atrial natriuretic peptide), and non-invasive cardiovascular stress MRI and pulmonary physiologic evaluation including spirometry, plethysmography and impulse oscillometry (IOS). Patients with active smoking history and/or asthma will be identified clinically.
Cardiovascular MRI will be performed using a 1.5T (Avanto or Espree, Siemens Healthcare) system. Standard cardiovascular techniques will be used for the assessment of myocardial and vascular structure and function, including T1-weighted, T2-weighted, late gadolinium enhancement, cine, tagged and phase contrast imaging in selected planes. Adenosine stress MRI will be performed for evaluation of underlying coronary artery or microvascular disease.
- Conditions
- Obesity, Cardiovascular Abnormalities
- Keywords
- pulmonary circulation
- Medical subject headings
- Obesity, Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of body mass & adiposity on airway mechanics and cardiovascular anatomy and physiology.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410487
- Sponsor's protocol ID
- 11-01998
- Status last verified
- Dec 2014
- First submitted
- 3 Aug 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weight Loss on Cardio-respiratory Function and Patient-centered Outcomes in an Underserved, Minority Population With Clinically Severe Obesity
- ClinicalTrials.gov ID
- NCT01410487
- Acronym / sponsor ID
- 11-01998
- Conditions
- Obesity, Cardiovascular Abnormalities
- Keywords
- pulmonary circulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-art diagnostic modalities before and after significant (20%) weight loss.
The investigators propose to perform stress cardiac MRI and pulmonary function testing with oscillometry before and after significant surgical weight loss in 150 severely obese patients with cardiopulmonary symptoms. Patients evaluated in the comprehensive Obesity Center at Bellevue Hospital who meet NIH Consensus Guidelines for Bariatric Surgery, who have cardiopulmonary symptoms, and who meet clinical criteria for cardiac stress testing and pulmonary function testing will be approached by the study personnel and offered enrollment. Informed consent will be obtained. Enrolled patients will undergo clinical evaluation with a detailed medical history including the Borg dyspnea scale, physical examination, laboratory testing including cardiopulmonary biomarkers (brain natriuretic peptide, C-reactive protein, atrial natriuretic peptide), and non-invasive cardiovascular stress MRI and pulmonary physiologic evaluation including spirometry, plethysmography and impulse oscillometry (IOS). Patients with active smoking history and/or asthma will be identified clinically.
Cardiovascular MRI will be performed using a 1.5T (Avanto or Espree, Siemens Healthcare) system. Standard cardiovascular techniques will be used for the assessment of myocardial and vascular structure and function, including T1-weighted, T2-weighted, late gadolinium enhancement, cine, tagged and phase contrast imaging in selected planes. Adenosine stress MRI will be performed for evaluation of underlying coronary artery or microvascular disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients utilizing the Bariatric Clinic services at Bellevue (City/Public) Hospital.
Key inclusion criteria (1 listed)
- Eligible patients for this study are patients who are booked for bariatric surgery and who have cardiopulmonary symptoms that require further cardiopulmonary testing prior to bariatric surgery.
Key exclusion criteria (1 listed)
- Patients with contraindications to MRI examination with gadolinium contrast and adenosine administration will be excluded. Additional exclusions include being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks), participation in other obesity- or diabetes-related clinical trials, or diagnosis of cognitive dysfunction or significant psychiatric comorbidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effects of body mass & adiposity on airway mechanics and cardiovascular anatomy and physiology.
Time frame: 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Cardiovascular Abnormalities, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of body mass & adiposity on airway mechanics and cardiovascular anatomy and physiology. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014; AzTrials last refreshed its copy on 2 Nov 2026.