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Gastric Sleeve
Bariatric Surgery for Obesity
N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will study the effects of bariatric surgery on dyspnea and quality of life in people with obesity. Improved understanding of this relationship can lead to better treatments.
Who is the study for?
This trial is for English/Spanish-speaking adults over 18 with obesity, experiencing shortness of breath and seeking gastric sleeve surgery at the Ronald Reagan medical center. They must understand questionnaires and give informed consent. Excluded are those with mental disorders, serious heart or lung diseases, past gastrointestinal surgeries, recent hospitalization, renal failure or cancer history.Check my eligibility
What is being tested?
The study examines how weight loss from bariatric surgery (gastric sleeve) affects shortness of breath in obese individuals. It aims to see if this surgical method can improve patients' quality of life by reducing dyspnea using a validated health questionnaire (PROMIS+HF 27).See study design
What are the potential side effects?
While not specified here, typical side effects from bariatric surgery may include nausea, vomiting, digestive issues like acid reflux or constipation, nutritional deficiencies due to reduced food intake and absorption changes post-surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dyspnea
Secondary outcome measures
Health related quality of life
Trial Design
2Treatment groups
Experimental Treatment
Group I: Medical weight lossExperimental Treatment1 Intervention
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.
Group II: Bariatric surgeryExperimental Treatment1 Intervention
Gastric sleeve resection will be performed by experienced surgeons. Postoperative care will follow UCLA's postoperative care pathways for gastric sleeve resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bariatric surgery
2013
Completed Phase 4
~15460
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterOTHER
1,048 Previous Clinical Trials
1,053,695 Total Patients Enrolled
Northwestern UniversityOTHER
1,589 Previous Clinical Trials
917,047 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,532 Previous Clinical Trials
10,265,228 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and answer questionnaires clearly.You have mental health issues or memory problems.I am having or have had weight loss surgery that is not a gastric sleeve, or I am having a gastric sleeve after another weight loss procedure.I have a serious heart condition.I have a lung condition.I have had surgery on my digestive system before.I have kidney failure.I have had cancer before.I speak English or Spanish.I am having gastric sleeve surgery for obesity at Ronald Reagan Medical Center.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Bariatric surgery
- Group 2: Medical weight loss
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings available for those wishing to participate in this clinical trial?
"According to clinicaltrials.gov, this medical trial is presently enrolling candidates. It was initially advertised on July 9th 2023 and has had its details updated as recently as the 12th of July in the same year."
Answered by AI
What is the total enrollment count of this clinical trial?
"Indeed, the information available on clinicaltrials.gov confirms that this study is actively recruiting patients. It was initially posted on July 9th 2023 and revised most recently on July 12th 2023. The medical trial aims to enrol 40 individuals from one single centre."
Answered by AI
Who else is applying?
What site did they apply to?
Surgery Departement, UCLA
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I,D LIKE TO TRY.
PatientReceived 2+ prior treatments
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