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

NCT05812183 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-02-14

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

Bariatric surgery

Gastric sleeve resection will be performed by experienced surgeons. Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection.

DRUG

Medical weight loss

The medical weight loss intervention will follow UCLA's RFO standard protocol. Over a period of 12 months, patients in the medical weight loss group will follow a very low caloric diet (VLCD) at the UCLA RFO program. All study patients will be prescribed a VLCD, an exercise regimen and will participate in group classes on behavioral modification. The caloric intake consists of a commercially prepared meal replacement powder supplying 700-800 cal/day. Each formula packet provides 100kcal and 15g of high biological value protein, and the daily allowance of required minerals and vitamins. Some patients may recieve adjuvant drug therapy including Orlistat (Xenical, Alli), Phentermine-topiramate (Qsymia), Naltrexone-bupropion (Contrave), Liraglutide (Saxenda), Semaglutide (Wegovy), Tirzepatide (Zepbound) or Setmelanotide (Imcivree).

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-09
Primary Completion
2025-02-12
Completion
2025-02-12
FDA Drug
Yes

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05812183 on ClinicalTrials.gov