Clinical trial NCT05812183: Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity
Official title: The Effect of Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Patients with Obesity: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Dyspnea
Quality of Life
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
name: Northwestern University
First posted: 2023-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Surgery is comapred with medical treatments for obesity. Some of the medical treatments will include treatments using FDA-approved medications
Primary purpose: TREATMENT

Brief summary: Most research to date on bariatric surgery outcomes has been about metabolic syndrome, a disorder very effectively treated by bariatric surgery. However, obesity is also associated with many other problems that have received much less attention. Amongst the most troubling of these for patients is dyspnea. Dyspnea results in substantial patient distress that can greatly reduce health-related quality of life. Little is known about the relationship between dyspnea, weight loss, and bariatric surgery. Dyspnea is a complex symptom that may lead to adaptive responses, such as the need to rest as a consequence of even minimal activity or seeking medical attention. The main outcome of the study will be measured using a new state-of-the-science validated HRQOL measure, the Patient Reported Outcome Measuring Information System for Heart Failure (PROMIS+HF 27).

Detailed description: The main purpose of this prospective matched cohort study is to determine the feasibility for a future, novel large-scale study, clinical trial that will aim to determine how common dyspnea is in obese patients, how much dyspnea affects their quality-of-life, and how these parameters are affected by medically or surgically induced weight loss. Our basic assumption is that dyspnea is more common than is commonly believed in obese patients and that it profoundly affects quality of life. Our main hypothesis is that weight loss improves dyspnea and HRQOL and that bariatric surgery induced weight loss is more effective than medical weight loss at improving dyspnea-related quality-of-life.

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥18 years of age.
2. All patients undergoing gastric sleeve resection for serious obesity at the Ronald Reagan medical center will be considered for enrollment in the experimental group.
3. English/Spanish speakers.
4. The patients included will be with preserved cognition and a capacity to understand questionnaires.
5. Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Serious cardiovascular disease, previous gastrointestinal surgery, psychological concerns (mental disorders and dementia), recently hospitalized, pulmonary diseases, renal failure, or history of malignancy.
2. Undergoing procedures other than gastric sleeve resection or are having these operations after they have had other bariatric procedures.
3. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.

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Primary outcomes:
measure: Dyspnea
timeFrame: 12 months
Secondary outcomes:
measure: Health related quality of life
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
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