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

NCT05812183 · Withdrawn

Last updated 2026-05-28

This clinical trial tests whether weight loss from gastric sleeve surgery improves shortness of breath in adults with obesity.

Status Withdrawn Stopped before any participant enrolled.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Non-randomized, single-blind treatment study

Who can join Ages 18+ · all sexes Healthy volunteers accepted.

Timeline Started 2023-07 · est. completion 2025-02

What this study is testing ClinicalTrials.gov NCT05812183 ↗

Description as written by the study sponsor.

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).

Treatments tested

Bariatric surgery Device

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

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).

Main thing measured	Dyspnea
Sponsor	University of California, Los Angeles
Conditions studied	Dyspnea, Quality of Life
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05812183 ↗