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Gastric Sleeve

Bariatric Surgery for Obesity

Phase 4

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

Must not have

Undergoing procedures other than gastric sleeve resection or are having these operations after they have had other bariatric procedures

Serious cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

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.

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).

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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I have a serious heart condition.

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I have had surgery on my digestive system before.

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I have kidney failure.

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I have had cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dyspnea

Secondary study objectives

Health related quality of life

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~15190

0 / 5Eligibility criteria met