Bariatric Surgery for Obesity

Overseen By Edward H Livingston

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Los Angeles

Disqualifiers: Cardiovascular, Gastrointestinal, Mental disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how bariatric surgery might alleviate breathing difficulties, known as dyspnea, in individuals with obesity. Researchers aim to determine if reducing stomach size through surgery can relieve this symptom and enhance quality of life. Participants will either undergo bariatric surgery or follow a medical weight loss program involving a low-calorie diet and exercise. Those who are seriously obese and experience breathing problems during daily activities may be suitable candidates for this study. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, providing participants an opportunity to benefit from established therapies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What is the safety track record for these treatments?

Research has shown that bariatric surgery is generally safe for people with obesity. The risk of death from the surgery is about 0.1%, and major complications occur in about 4% of cases. Sleeve gastrectomy, a common type of bariatric surgery, is linked to a lower long-term risk of death and has a relatively low complication rate. One study found that only about 4.6% of patients experienced problems within 30 days after the procedure.

In contrast, medical weight loss programs, such as very low-calorie diets, are also considered safe. These programs do not involve surgery and focus on changes in diet and lifestyle. Studies have shown that participants in these programs can lose significant weight without major safety concerns.

Both treatments have been used successfully and are generally well-tolerated. However, consulting a healthcare provider is important to determine which option may be safer and more effective for individual health needs. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for obesity because they offer distinct approaches to weight loss. Bariatric surgery, specifically gastric sleeve resection, physically reduces stomach size, which limits food intake and alters hunger-related hormones, potentially leading to significant long-term weight reduction. On the other hand, the medical weight loss intervention combines a very low-calorie diet (VLCD), exercise, and behavioral therapy, which can be less invasive than surgery and focuses on sustainable lifestyle changes. While standard options often include lifestyle changes, medications, or various surgical methods, these treatments provide tailored solutions that could address the needs of different patient profiles more effectively.

What evidence suggests that this trial's treatments could be effective for dyspnea?

Research shows that bariatric surgery, one of the treatments in this trial, effectively aids weight loss. Studies have found that procedures like sleeve gastrectomy can lead to a loss of up to 58.8% of excess weight within five years. This surgery not only promotes weight loss but also maintains it more effectively than other methods. Although primarily studied for its impact on metabolic syndrome, the weight loss from bariatric surgery can also alleviate issues like shortness of breath. In contrast, medical weight loss programs, another treatment option in this trial, can help some individuals lose 5-10% of their weight, but these results tend to be less consistent and smaller compared to surgery. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can understand and answer questionnaires clearly.

Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study

I am having gastric sleeve surgery for obesity at Ronald Reagan Medical Center.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either gastric sleeve surgery or follow a medical weight loss program with a very low-calorie diet

12 months

Follow-up

Participants are monitored for changes in dyspnea and health-related quality of life using PROMIS+HF 27

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bariatric surgery
• Medical weight loss

Trial Overview

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).

How Is the Trial Designed?

Group I: Medical weight loss Experimental Treatment 1 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 surgery Experimental Treatment 1 Intervention

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

Bariatric surgery is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Gastric Sleeve Surgery for:

• Severe Obesity
• Obesity-related conditions such as type 2 diabetes, high blood pressure, and sleep apnea

Approved in European Union as Sleeve Gastrectomy for:

• Morbid Obesity
• Obesity-related comorbidities

Approved in Canada as Bariatric Surgery for:

• Class III Obesity
• Obesity-related health issues

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

In a study of 47 patients who underwent videolaparoscopic sleeve gastrectomy, the average percentage of excess weight loss was 85.46%, indicating significant weight reduction post-surgery.

Quality of life improvements were substantial, with 76.6% of patients reporting excellent to good outcomes on the BAROS questionnaire, and all investigated comorbidities showed clinical improvement after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QUALITY OF LIFE AFTER VERTICAL GASTRECTOMY EVALUATED BY THE BAROS QUESTIONNAIRE. Vargas, GP., Mendes, GA., Pinto, RD.[2022]

Surgical weight loss procedures significantly improve or resolve obesity-related medical issues for most patients, but the long-term effects on sustained weight loss and health improvements are still uncertain.

The American Society of Bariatric Surgery's new computer registry aims to standardize outcome analysis and improve patient selection for surgeries, which could enhance the effectiveness of weight loss interventions and ultimately improve health outcomes for morbidly obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of obesity surgery. Brolin, RE.[2005]

In a study of 47 patients who underwent videolaparoscopic sleeve gastrectomy, there was an impressive average weight loss of 85.46% of excess weight, which significantly contributed to improved quality of life.

Post-surgery, patients reported excellent to very good improvements in quality of life, with all investigated comorbidities showing clinical improvement, highlighting the effectiveness of this surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QUALITY OF LIFE AFTER VERTICAL GASTRECTOMY EVALUATED BY THE BAROS QUESTIONNAIRE. Mendes, GA., Vargas, GP.[2018]

In a study of 194,248 adults who underwent bariatric surgery, sleeve gastrectomy (SG) was found to have a significantly lower 30-day hospital readmission rate and fewer emergency room visits compared to Roux-en-Y gastric bypass (RYGB).

However, while SG showed lower overall complication rates, it was associated with a higher risk of needing revisional surgery compared to RYGB, indicating a trade-off between immediate safety and long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Safety of Sleeve Gastrectomy and Roux-en-Y: A Propensity Score Analysis. Alalwan, AA., Friedman, J., Park, H., et al.[2022]

In a study of 100 patients who underwent laparoscopic sleeve gastrectomy (LSG), those with a greater than 50% excess weight loss (EWL) had significantly lower post-operative Body Mass Index (BMI) after six months, indicating effective weight loss outcomes.

Factors such as higher pre-operative BMI, childhood onset of obesity, less pre-operative weight loss, and lower compliance with dietary instructions were associated with poorer weight loss results, highlighting the importance of addressing these issues for better post-surgery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cross-sectional survey of patients attending follow-up visits after sleeve gastrectomy: Factors affecting weight loss. Hany, M., Hafez Mohammad, MK., Abd Elhafeez, NA., et al.[2023]

In a study of 109 patients with obesity and type 2 diabetes, gastric bypass surgery resulted in significantly greater improvements in weight-related quality of life, weight loss (25% vs 17%), and diabetes remission (67% vs 33%) compared to sleeve gastrectomy after 3 years.

Gastric bypass also led to fewer reflux symptoms compared to sleeve gastrectomy, while both procedures showed similar rates of other complications like abdominal pain and depression, providing valuable insights for patient decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes, weight loss, and remission of type 2 diabetes 3 years after gastric bypass and sleeve gastrectomy (Oseberg); a single-centre, randomised controlled trial. Svanevik, M., Lorentzen, J., Borgeraas, H., et al.[2023]

Both sleeve gastrectomy (SG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) resulted in increased diversity and gene richness of gut microbiota after surgery, indicating positive changes associated with weight loss in obese patients.

However, LRYGB led to a greater shift in microbial composition, with an increase in aero-tolerant bacteria and functional changes that may enhance nutrient absorption, suggesting that the type of bariatric surgery can significantly influence gut health and microbiome dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy on gut microbiota: a metagenomic comparative analysis. Farin, W., Oñate, FP., Plassais, J., et al.[2021]

In a study of 8966 patients who underwent gastric bypass or sleeve gastrectomy over a 7-year period, those who had surgery experienced lower mortality rates compared to matched control patients with obesity, indicating a potential long-term benefit of these procedures.

However, patients who underwent gastric bypass or sleeve gastrectomy had a significantly higher risk of hospital admissions for late adverse events, particularly gastrointestinal and nutritional disorders, compared to control patients, with gastric bypass showing a greater risk than sleeve gastrectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term adverse events after sleeve gastrectomy or gastric bypass: a 7-year nationwide, observational, population-based, cohort study. Thereaux, J., Lesuffleur, T., Czernichow, S., et al.[2020]

In a study of 38,153 bariatric surgery patients, sleeve gastrectomy was associated with fewer re-interventions (9.9% vs. 15.6%) and complications (6.6% vs. 9.6%) compared to gastric bypass after 2 years, indicating a better safety profile for sleeve gastrectomy.

Despite its overall safety advantages, sleeve gastrectomy had a slightly higher rate of revisions (0.6% vs. 0.4%) compared to gastric bypass, suggesting that while it is safer, the risk of needing further surgery should be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Safety of Sleeve Gastrectomy and Gastric Bypass: An Instrumental Variables Approach. Chhabra, KR., Telem, DA., Chao, GF., et al.[2022]

In a study of 95,251 adults undergoing bariatric surgery, Roux-en-Y gastric bypass (RYGB) had the highest rate of 30-day adverse events (3.8%) compared to adjustable gastric banding (AGB) and sleeve gastrectomy (SG), which had rates of 3.1% and 2.8%, respectively.

RYGB also showed higher hospitalization rates and mortality compared to AGB and SG, indicating that while RYGB may be effective, it carries more immediate and long-term risks than the other procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions and Operations after Bariatric Surgery in a Health Plan Research Network Cohort from the PCORnet, the National Patient-Centered Clinical Research Network. Ma, Q., Shambhu, S., Arterburn, DE., et al.[2021]

In a study of 3287 patients, both sleeve gastrectomy (SG) and gastric bypass (GB) were effective in treating obesity and its related health issues, with significant improvements in quality of life observed after both procedures.

SG had a lower complication rate and fewer nutritional deficiencies compared to GB, making it a safer option, especially for patients with a healthier metabolic profile, despite GB showing slightly better remission rates for hypertension and dyslipidemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year outcomes of sleeve gastrectomy versus gastric bypass: first report based on Tehran obesity treatment study (TOTS). Khalaj, A., Tasdighi, E., Hosseinpanah, F., et al.[2020]

Laparoscopic sleeve gastrectomy is a highly effective and safe surgical option for treating obesity and type 2 diabetes mellitus, making it a popular choice in bariatric surgery.

The review highlights the significant efficacy of this procedure, indicating its growing acceptance and application in the field of metabolic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the application of laparoscopic sleeve gastrectomy in bariatric and metabolic surgery]. Xu, B., Yao, QY.[2018]

Bariatric surgery is a safe and effective option for long-term weight loss in patients with morbid obesity, with various procedures available including gastric restrictive and malabsorptive techniques.

The laparoscopic approach enhances recovery after surgery, and careful patient selection is crucial, as many obesity-related medical conditions improve following weight loss from the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of the art in bariatric surgery for weight loss in the morbidly obese patient. Hamad, GG.[2005]

Laparoscopic sleeve gastric resection is an effective surgical option for treating morbid obesity, focusing on reducing body mass through a minimally invasive procedure.

The study highlights the safety of the intervention, indicating that it can lead to significant weight loss while minimizing risks associated with traditional open surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Laparoscopic sleeve gastric resection: experience of Bariatric Department in University of Cyprus, Greece]. Melissas, J., Daskalakis, M., Askoksilakis, I.[2016]

Laparoscopic sleeve gastrectomy (LSG) is a safe and effective weight-loss surgery, showing significant weight loss of approximately 89.3 lb after one year and 87.5 lb after two years in patients, with a low complication rate (only 12 complications reported, including one death).

The procedure also led to a high rate of diabetes resolution, with 82% of diabetic patients cured and others experiencing reduced medication needs, indicating its potential metabolic benefits beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic sleeve gastrectomy: a retrospective review of 1- and 2-year results. Jacobs, M., Bisland, W., Gomez, E., et al.[2021]

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