WithdrawnPhase 4

Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity

Stopped: Conducted an interim analysis on similar data

0Started 2023-07-09

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Serious cardiovascular disease, previous gastrointestinal surgery, psychological concerns (mental disorders and dementia), recently hospitalized, pulmonary diseases, renal failure, or history of malignancy.
✕. Undergoing procedures other than gastric sleeve resection or are having these operations after they have had other bariatric procedures.
✕. 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.

What they're measuring

Dyspnea

Timeframe: 12 months

Trial details

NCT IDNCT05812183

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-12

View on ClinicalTrials.gov More Dyspnea trials