Weight Loss Surgery Outcomes for Obesity

Overseen By Negin Fadaee, BS MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Feiz & Associates

Disqualifiers: Pregnancy, BMI below 30, others

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

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

Compensation: Varies

Number of Visits: 5

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how weight loss surgery (also known as bariatric or metabolic surgery) affects individuals with a BMI between 30 and 34.5 kg/m². Researchers seek to learn about changes in health, mood, and quality of life following the surgery. The focus is on individuals without other health issues like diabetes or high blood pressure. Ideal candidates for this trial have a BMI in this range and are medically cleared for cosmetic weight loss surgery. Participants will complete surveys about their body image and self-esteem before and after surgery to gather this information. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance understanding of weight loss surgery's broader impacts.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that weight loss surgery is safe for patients with a BMI under 35 kg/m²?

Research shows that weight loss surgery is generally safe for patients. The risk of death from these surgeries is about 0.1%, and the chance of major complications is around 4%, indicating that most people handle the surgery well.

One study found that patients who underwent these surgeries were less likely to develop serious health issues related to obesity. While the surgery has been well studied in individuals with higher body mass indexes (BMIs), researchers are now examining its effects on those with a BMI between 30 and 34.5. Although less information exists for this group, existing research on weight loss surgery indicates it is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about weight loss surgery for obesity because it offers a potential solution for patients with a BMI between 30-34.5 kg/m² who might not be eligible for traditional weight loss surgeries. Unlike other treatments that primarily involve lifestyle changes or medications, this surgical approach directly alters the digestive system, potentially leading to significant and sustained weight loss. Additionally, by assessing the impact on body image and self-esteem at multiple intervals post-surgery, this method aims to provide a comprehensive understanding of the surgery's benefits beyond just physical health. This could offer new insights into improving overall quality of life for patients struggling with obesity.

What is the effectiveness track record for weight loss surgery in patients with BMI under 35 kg/m²?

Research shows that weight loss surgery, the focus of this trial, is highly effective for losing weight. Studies indicate that individuals undergoing these surgeries lose significantly more weight than those relying solely on medication or lifestyle changes. For instance, one study found that bariatric surgery resulted in about twice the weight loss compared to non-surgical methods over several years. Another study demonstrated that surgery led to about five times more weight loss than certain weight-loss drugs. Additionally, the surgery often improves health issues like diabetes and heart health. Although limited research exists for individuals with a BMI under 35, this trial will explore the surgery's effectiveness for weight loss in this group. ^{1 5 6 7 8}

Who Is on the Research Team?

Michael Feizbakhsh, MD

Principal Investigator

Dr. Feiz and Associates

Are You a Good Fit for This Trial?

This trial is for individuals with a BMI between 30 and 34.5 who are healthy enough for cosmetic weight loss surgery but don't have other health issues like diabetes or high blood pressure. Participants must be able to give informed consent and follow study procedures.

Inclusion Criteria

Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with the requirements of the study

My BMI is between 30 and 34.5, and I am cleared for weight loss surgery without any other health issues.

Exclusion Criteria

I am not cleared for weight loss surgery due to medical reasons.

Patients with BMI above 34.5 kg/m2

Patients who are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo weight loss surgery

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for changes in health, mood, quality of life, health satisfaction, and emotional health

12 months

4 visits (in-person) at 1, 3, 6, and 12 months post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Body Image/Self-Esteem Questionnaires
• Weight Loss Surgery

Trial Overview The study aims to assess patient-reported outcomes after weight loss surgery in low-risk patients, focusing on changes in health, mood, quality of life, satisfaction with their health status, and emotional well-being.

How Is the Trial Designed?

Group I: Patients with BMI between 30-34.5 kg/m2 Experimental Treatment 1 Intervention

Patients with BMI between 30-34.5 kg/m2 will be administered a body image/self-esteem questionnaire pre-operatively and at 1 month, 3 months, 6 months and 12 months post-operatively.

Weight Loss Surgery is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Bariatric Surgery for:

• Obesity with BMI ≥ 40 kg/m²
• Obesity with BMI ≥ 35 kg/m² and at least one obesity-related comorbidity

Approved in European Union as Bariatric Surgery for:

• Obesity with BMI ≥ 40 kg/m²
• Obesity with BMI ≥ 35 kg/m² and at least one obesity-related comorbidity

Approved in Canada as Bariatric Surgery for:

• Obesity with BMI ≥ 40 kg/m²
• Obesity with BMI ≥ 35 kg/m² and at least one obesity-related comorbidity

Who Is Running the Clinical Trial?

Dr. Feiz & Associates

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Roux-en-Y gastric bypass (RYGB) in patients with class I obesity (BMI 30.0-34.9 kg/m²) and type 2 diabetes resulted in significant weight loss (BMI decreased from 34.6 to 25.8 kg/m²) and improved glycemic control (HbA1c decreased from 8.2% to 6.1%) after one year, while the nonsurgical control group showed no significant changes.

Patients who underwent RYGB also reduced their use of antihypertensive and antihyperlipidemia medications, although this may have contributed to persistent high blood pressure and LDL cholesterol levels, indicating a need for careful medication management post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of bariatric surgery and nonsurgical therapy in adults with type 2 diabetes mellitus and body mass index Serrot, FJ., Dorman, RB., Miller, CJ., et al.[2022]

A systematic review of 90 studies, including 39 randomized controlled trials, revealed that bariatric surgery outcomes are reported inconsistently, with 85% of the 1,088 outcomes identified reported only once, highlighting the need for standardized reporting.

The majority of outcomes focused on 'surgical complications' and adverse events, with only a quarter of outcomes having clear definitions, which limits the ability to compare results across studies. This underscores the importance of developing a core outcome set (COS) for bariatric surgery to improve clarity and consistency in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome reporting in bariatric surgery: an in-depth analysis to inform the development of a core outcome set, the BARIACT Study. Hopkins, JC., Howes, N., Chalmers, K., et al.[2021]

In a study of 266,544 patients undergoing laparoscopic bariatric surgery, older age was linked to a higher risk of various complications, except for venous thromboembolism and 30-day mortality.

Patients who had Roux-en-Y gastric bypass experienced worse outcomes compared to those who had sleeve gastrectomy, indicating that the type of procedure also influences perioperative risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Age Confers a Higher Risk of 30-Day Morbidity and Mortality Following Laparoscopic Bariatric Surgery: an Analysis of the Metabolic and Bariatric Surgery Quality Improvement Program. Haskins, IN., Ju, T., Whitlock, AE., et al.[2019]

Endoscopic management is a key first-line approach for addressing adverse events following bariatric surgery, such as ulcers, stenoses, and leaks, utilizing various devices like balloon dilators and stents.

This method is less invasive compared to traditional surgical interventions and often requires a multidisciplinary team, indicating its growing importance in the evolving treatment algorithms for bariatric surgery complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic devices and techniques for the management of bariatric surgical adverse events (with videos). Schulman, AR., Watson, RR., Abu Dayyeh, BK., et al.[2021]

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]

Bariatric surgery outcomes have improved significantly from 2007 to 2018, with a notable reduction in 30-day surgical complications from 6% to 2.9% and medical complications from 3.4% to 1.7% after the implementation of the MBSAQIP.

The MBSAQIP era is linked to a higher likelihood of early patient discharge (from 9.8% to 46.9%) and lower odds of complications, indicating enhanced safety and efficacy of bariatric procedures during this period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program and outcomes of bariatric surgery. Al-Mazrou, AM., Bellorin, O., Dakin, G., et al.[2023]

Bariatric surgery has seen a significant reduction in perioperative mortality rates, dropping from 1.5-2% in the past to just 0.04-0.3% in recent studies involving thousands of patients, indicating improved safety over time.

Despite advancements, serious complications still occur in 1-4% of patients, particularly with malabsorptive procedures, highlighting the need for ongoing nutritional support and monitoring for issues like intestinal obstruction and anastomotic stricture post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric/metabolic surgery: short- and long-term safety. Kim, JH., Wolfe, B.[2021]

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 44 patients undergoing obesity surgery, the actual weight loss achieved (BMI of 33.9 kg/m2) was comparable to their expected weight loss goal (BMI of 32.6 kg/m2), indicating that patients' expectations were met within 24 months post-surgery.

Quality of life (QOL) significantly improved after surgery, independent of the amount of weight lost or body shape changes, and patients increasingly attributed their weight loss success to the surgery itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perspective in Obesity Surgery: Goals for Weight Loss and Improvement of Body Shape in a Prospective Cohort Study. Nickel, F., Schmidt, L., Sander, J., et al.[2020]

In a study of 1012 patients who underwent metabolic surgery, African Americans experienced lower percent total weight loss (%TWL) compared to non-Hispanic/Latino Whites at multiple follow-up points, indicating potential disparities in outcomes based on ethnicity.

Patients who underwent Roux-en-Y gastric bypass (RYGB) achieved greater %TWL than those who had sleeve gastrectomy (SG) at various time intervals, suggesting that the type of surgical procedure may influence long-term weight loss success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Weight Loss After Metabolic Surgery in a Multiethnic Sample of 1012 Patients. Masrur, M., Bustos, R., Sanchez-Johnsen, L., et al.[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]

Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) lead to similar weight loss after 5 years, but duodenal switch procedures result in the greatest weight loss and best resolution of obesity-related diseases.

Bariatric surgery significantly reduces the risk of coronary artery disease and heart failure, especially in patients who are not insulin-dependent before surgery, although SG is linked to high rates of postoperative gastroesophageal reflux disease (GERD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes in Bariatric and Metabolic Surgery: an Updated 5-Year Review. Roth, AE., Thornley, CJ., Blackstone, RP.[2021]

Bariatric surgery is effective not only for weight loss but also for resolving metabolic disorders, such as type II diabetes, with remission rates as high as 95%, especially with malabsorptive procedures.

A retrospective analysis of 518 patients who underwent laparoscopic bariatric surgeries showed that this approach is safe and leads to significant excess body weight loss and improvement in related health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bariatric to metabolic surgery: management options and experience at a tertiary centre. Raj, PP., Chandramaliteeswaran, C., Senthilnathan, P., et al.[2011]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10353499/

Long-term effectiveness, outcomes and complications of ... This review aims to synthesize and summarize the growing evidence on the long-term effectiveness, outcomes and complications of bariatric surgery.

2. asmbs.org asmbs.org/news_releases/head-to-head-study-shows-bariatric-surgery-superior-to-glp-1-drugs-for-weight-loss/

Head-to-head Study Shows Bariatric Surgery Superior ... Sleeve gastrectomy and gastric bypass were associated with about five-times more weight loss than weekly injections of GLP-1 receptor agonists semaglutide or ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8241285/

Outcomes of Bariatric Surgery: Patients with Body Mass ... Few studies compare the effectiveness of one surgical procedure to another in patients with BMI > 60 kg/m2 and therefore the optimal bariatric procedure has yet ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2815401

Long-Term Outcomes of Medical Management vs Bariatric ... Percent weight loss at year 7 in the higher BMI group was 10.1% for the medical/lifestyle group and 19.3% for the bariatric surgery group ...

5. pcori.org pcori.org/research-results/2015/comparing-three-types-weight-loss-surgery-pcornetr-bariatric-study

Comparing Three Types of Weight Loss Surgery One year after surgery, youth who had RYGB lost an average of 31 percent of their body mass index, or BMI. Youth who had SG lost an average of ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838651

Bariatric Surgery and Obesity-Related Comorbidities In this cohort study, patients who underwent bariatric surgery showed a significantly decreased risk of developing major metabolic comorbidities ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9834364/

2022 American Society of Metabolic and Bariatric Surgery ... Individuals with BMI >60 kg/m2 are considered to be at especially high risk for surgery since these patients have greater obesity-associated disease burden and ...

8. asmbs.org asmbs.org/resources/metabolic-and-bariatric-surgery/

Resource Categories The risk of death associated with bariatric surgery is about 0.1% and the overall likelihood of major complications is about 4%.