Back to resultsGastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity
Primary Purpose
Dyspnea, Quality of Life
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bariatric surgery
Medical weight loss
Sponsored by
About this trial
This is an interventional treatment trial for Dyspnea
Eligibility Criteria
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. -
Sites / Locations
- Surgery Departement, UCLARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bariatric surgery
Medical weight loss
Arm Description
Gastric sleeve resection will be performed by experienced surgeons. Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection.
The medical weight loss intervention will follow the University of California at Los Angeles's (UCLA) Research For Obesity (RFO) standard protocol. Over a period of 12 months, patients in the medical weight loss group will follow a very loc 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.
Outcomes
Primary Outcome Measures
Dyspnea
Will be assessed using the PROMIS+HF 27 will be administered via RedCap for patients both groups.
PROMIS+HF 27 is part of a National Institutes of Health initiative to develop state-of-the art measures for quality of life. PROMIS+HF 27 contains 3 questions about dyspnea severity. Each of them can be assessed individually or the 3 combined to increase measurement precision into a dyspnea severity domain score.
Secondary Outcome Measures
Health related quality of life
Will be assessed using the PROMIS+HF 27 will be administered via RedCap for patients both groups.
PROMIS+HF 27 is part of a National Institutes of Health initiative to develop state-of-the art measures for quality of life.
Full Information
NCT ID
NCT05812183
First Posted
March 31, 2023
Last Updated
July 12, 2023
Sponsor
University of California, Los Angeles
Collaborators
University of Texas Southwestern Medical Center, Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05812183
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
University of Texas Southwestern Medical Center, Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bariatric surgery
Arm Type
Experimental
Arm Description
Gastric sleeve resection will be performed by experienced surgeons. Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection.
Arm Title
Medical weight loss
Arm Type
Experimental
Arm Description
The medical weight loss intervention will follow the University of California at Los Angeles's (UCLA) Research For Obesity (RFO) standard protocol. Over a period of 12 months, patients in the medical weight loss group will follow a very loc 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.
Intervention Type
Device
Intervention Name(s)
Bariatric surgery
Intervention Description
Gastric sleeve resection will be performed by experienced surgeons. Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection.
Intervention Type
Behavioral
Intervention Name(s)
Medical weight loss
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dyspnea
Description
Will be assessed using the PROMIS+HF 27 will be administered via RedCap for patients both groups.
PROMIS+HF 27 is part of a National Institutes of Health initiative to develop state-of-the art measures for quality of life. PROMIS+HF 27 contains 3 questions about dyspnea severity. Each of them can be assessed individually or the 3 combined to increase measurement precision into a dyspnea severity domain score.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Health related quality of life
Description
Will be assessed using the PROMIS+HF 27 will be administered via RedCap for patients both groups.
PROMIS+HF 27 is part of a National Institutes of Health initiative to develop state-of-the art measures for quality of life.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hila Zelicha
Phone
+1-424-768-0902
Email
hzelicha@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Edward H Livingston
Email
elivingston@mednet.ucla.edu
Facility Information:
Facility Name
Surgery Departement, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hila Zelicha
Phone
424-768-0902
Email
hila.zelicha@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity
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