Bariatric Surgery for Obesity

Recruiting in Los Angeles (>99 mi)

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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the idea that Bariatric Surgery for Obesity is an effective treatment?

The available research shows that bariatric surgery, such as sleeve gastrectomy, leads to significant weight loss and improvements in obesity-related health problems. It also enhances the quality of life for patients. Compared to other treatments, surgery offers the most realistic hope for long-term weight loss in people with severe obesity. While there are challenges in measuring long-term success, the surgery is currently the best option for achieving substantial weight loss and improving health outcomes. ^{1 2 3 4 5}

What safety data is available for bariatric surgery?

Several studies provide safety data for bariatric surgery, particularly comparing sleeve gastrectomy and gastric bypass. The Tehran Obesity Treatment Study (TOTS) reports on the effectiveness and safety of these procedures over two years. A propensity score analysis and an instrumental variables approach both compare the safety of sleeve gastrectomy and Roux-en-Y gastric bypass, focusing on outcomes like hospital readmissions, ER visits, gastrointestinal bleeding, and revisional surgery. A 7-year nationwide cohort study assesses long-term adverse events for these surgeries. Additionally, a study from the PCORnet network examines short-term (30-day) and long-term (up to 5 years) safety outcomes, including interventions, operations, endoscopy, hospitalization, and mortality. ^{6 7 8 9 10}

Is bariatric surgery a promising treatment for obesity?

Yes, bariatric surgery, including gastric sleeve surgery, is a promising treatment for obesity. It is effective for significant weight loss and improving health conditions like type 2 diabetes. The surgery is safe, and patients recover quickly, making it a popular choice for those struggling with severe obesity. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

QUALITY OF LIFE AFTER VERTICAL GASTRECTOMY EVALUATED BY THE BAROS QUESTIONNAIRE. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Results of obesity surgery. [2005]

3. Brazil pubmed.ncbi.nlm.nih.gov

QUALITY OF LIFE AFTER VERTICAL GASTRECTOMY EVALUATED BY THE BAROS QUESTIONNAIRE. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A cross-sectional survey of patients attending follow-up visits after sleeve gastrectomy: Factors affecting weight loss. [2023]

5. England 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Comparative Safety of Sleeve Gastrectomy and Roux-en-Y: A Propensity Score Analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Long-term adverse events after sleeve gastrectomy or gastric bypass: a 7-year nationwide, observational, population-based, cohort study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Comparative Safety of Sleeve Gastrectomy and Gastric Bypass: An Instrumental Variables Approach. [2022]

9. United States 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. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Two-year outcomes of sleeve gastrectomy versus gastric bypass: first report based on Tehran obesity treatment study (TOTS). [2020]

11. China pubmed.ncbi.nlm.nih.gov

[Evaluation of the application of laparoscopic sleeve gastrectomy in bariatric and metabolic surgery]. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

Impact of laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy on gut microbiota: a metagenomic comparative analysis. [2021]

14. Ukraine pubmed.ncbi.nlm.nih.gov

[Laparoscopic sleeve gastric resection: experience of Bariatric Department in University of Cyprus, Greece]. [2016]

15. Germany pubmed.ncbi.nlm.nih.gov

Laparoscopic sleeve gastrectomy: a retrospective review of 1- and 2-year results. [2021]