- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05812183
Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity
The Effect of Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Patients With Obesity: A Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hila Zelicha
- Phone Number: +1-424-768-0902
- Email: hzelicha@mednet.ucla.edu
Study Contact Backup
- Name: Edward H Livingston
- Email: elivingston@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- Recruiting
- Surgery Departement, UCLA
-
Contact:
- Hila Zelicha
- Phone Number: 424-768-0902
- Email: hila.zelicha@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bariatric surgery
Gastric sleeve resection will be performed by experienced surgeons.
Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection.
|
Gastric sleeve resection will be performed by experienced surgeons.
Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection.
|
Experimental: Medical weight loss
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea
Time Frame: 12 months
|
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. |
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life
Time Frame: 12 months
|
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. |
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-001915
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaActive, not recruitingImprove Quality of LifeItaly
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life
Clinical Trials on Bariatric surgery
-
Centre Hospitalier Universitaire de NiceTerminatedObesity | Chronic Kidney DiseaseFrance
-
Imperial College LondonRecruitingObesity | Type 2 DiabetesIreland
-
McMaster UniversityNot yet recruitingRobotic Surgery | Bariatric Surgery
-
Vanderbilt University Medical CenterNational Cancer Institute (NCI); National Institute of Diabetes and Digestive...RecruitingCardiovascular Diseases | Hypertension | Dyslipidemias | Type 2 Diabetes | Morbid Obesity | Bariatric Surgery CandidateUnited States
-
Guy's and St Thomas' NHS Foundation TrustRecruitingObesity Hypoventilation Syndrome (OHS)United Kingdom
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Rabin Medical CenterRecruiting
-
V.K.V. American Hospital, IstanbulCompletedBariatric Surgery Candidate | Post Operative Pain | Regional Anesthesia MorbidityTurkey
-
Hacettepe UniversityCompleted