Weight Loss Surgery for Obesity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Beta blockers, Corticosteroids

Disqualifiers: Diabetes, Coronary artery disease, Smoking, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how significant weight loss through gastric sleeve surgery (also known as bariatric surgery) affects the body's ability to break down fats, particularly concerning inflammation. Researchers aim to observe changes when individuals lose weight and maintain it after surgery. Individuals with a BMI between 40 and 50, without diabetes or certain other health issues, may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding the broader health impacts of bariatric surgery.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications known to affect fat tissue metabolism, such as beta blockers and corticosteroids.

What prior data suggests that gastric sleeve surgery is safe for weight loss?

Research has shown that gastric sleeve surgery is generally safe for individuals seeking weight loss. Studies have identified this surgery as the most popular method for treating severe obesity in the U.S. One study discovered a low risk of death and complications, even five years post-procedure, with no deaths and a small leakage rate of 1.2%.

Other research suggests that this surgery results in fewer complications compared to other weight-loss surgeries, reducing the need for additional surgeries later. The procedure involves removing about 80% of the stomach, aiding weight loss and lowering health risks related to obesity. These findings support the conclusion that gastric sleeve surgery is well-tolerated and effective for many individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Gastric sleeve surgery is unique because it involves the removal of a large portion of the stomach, reducing its size and limiting food intake, which can lead to significant weight loss. Unlike other treatments for obesity, such as lifestyle changes or medication, this surgery provides a more permanent solution by physically altering the digestive system. Researchers are excited because it not only helps with weight loss but also has the potential to improve or resolve obesity-related conditions, like type 2 diabetes, more effectively than less invasive methods.

What is the effectiveness track record for gastric sleeve surgery in treating obesity?

Research has shown that gastric sleeve surgery, which participants in this trial will undergo, helps people lose a significant amount of weight. One study found that patients lost about 42% of their excess weight over ten years. Another study found that this surgery is safe, with few complications, and helps maintain weight loss for at least five years. Additionally, surgeries like the gastric sleeve can improve type 2 diabetes, with many patients experiencing improvement or even resolution of their diabetes after surgery. Overall, evidence supports that gastric sleeve surgery can lead to long-term weight loss and health benefits. ^{2 4 6 7 8}

Who Is on the Research Team?

Michael D Jensen, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with severe obesity (BMI 40-50) who haven't been exercising regularly or taking certain medications that affect fat metabolism. It's not for those with active physical illnesses, liver disease, diabetes, kidney issues, heart disease, smokers, or pregnant/breastfeeding individuals.

Inclusion Criteria

I don't have any illnesses that would stop me from moving around or losing weight after weight-loss surgery.

You have a body mass index (BMI) between 40 and 50 kg/m2, which means you are significantly overweight or obese.

I don't have any illnesses that would stop me from moving around or losing weight after weight-loss surgery.

Exclusion Criteria

You exercise regularly for at least 30 minutes, twice a week.

You are a smoker.

I have active heart artery disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Assessment

Participants undergo studies of insulin regulation of FFA release and adipose biopsies before bariatric surgery

1-2 weeks

Bariatric Surgery

Participants undergo gastric sleeve surgery for substantial weight loss

1 week

Post-Surgery Follow-up

Participants are monitored for changes in insulin regulation of lipolysis and adipose tissue inflammation one year after surgery

1 year

Long-term Follow-up

Participants are monitored for long-term effects on insulin regulation and adipose tissue changes

Additional 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Gastric Sleeve/Bariatric Surgery

Trial Overview The study investigates how well bariatric surgery (sleeve gastrectomy) helps people lose a lot of weight and improves the way their bodies use insulin to break down fats. Researchers will compare inflammation and fat breakdown before and after surgery.

How Is the Trial Designed?

Group I: Gastric sleeve surgery Experimental Treatment 1 Intervention

before and after weight loss from bariatric surgery

Gastric Sleeve/Bariatric Surgery is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sleeve Gastrectomy for:

• Obesity
• Type 2 diabetes
• Hypertension
• Sleep apnea
• Fatty liver disease
• High cholesterol

Approved in European Union as Sleeve Gastrectomy for:

• Obesity
• Type 2 diabetes
• Hypertension
• Sleep apnea
• Fatty liver disease
• High cholesterol

Approved in Canada as Sleeve Gastrectomy for:

• Obesity
• Type 2 diabetes
• Hypertension
• Sleep apnea
• Fatty liver disease
• High cholesterol

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Laparoscopic vertical sleeve gastrectomy (LSG) shows excellent weight loss outcomes, with an average excess weight loss of nearly 50% at 3 months and up to 78.7% for patients with a BMI ≤43.0 after 36 months, based on a study of 204 patients.

The procedure has a very low complication rate, with serious issues like leaks and abscesses occurring in less than 1% of cases, supporting LSG as a safe and effective stand-alone treatment for morbid obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic sleeve gastrectomy is a safe and effective bariatric procedure for the lower BMI (35.0-43.0 kg/m2) population. Gluck, B., Movitz, B., Jansma, S., et al.[2021]

After 5 years post-vertical sleeve gastrectomy (VSG), patients maintained significant weight loss, with a mean body mass index (BMI) reduction from 46.2 kg/m2 to 32.9 kg/m2, indicating the procedure's long-term efficacy in obesity management.

The surgery led to substantial improvements in obesity-related conditions, with 63% of patients experiencing remission of type 2 diabetes and 60% for hypertension at 5 years, although there was an increase in gastroesophageal reflux disease (GERD) cases over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Year Outcomes After Vertical Sleeve Gastrectomy for Severe Obesity: A Prospective Cohort Study. Flølo, TN., Andersen, JR., Kolotkin, RL., et al.[2018]

Laparoscopic vertical sleeve gastrectomy is a highly effective and safe option for weight loss in obese patients, offering similar results to more complex bariatric surgeries.

The procedure requires careful consideration of patient comorbidities and the surgeon's expertise to ensure optimal outcomes, making it a powerful tool against obesity and its related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic Vertical Sleeve Gastrectomy. Climaco, K., Ahnfeldt, E.[2021]

Vertical sleeve gastrectomy (VSG) led to significant weight loss in adolescents with obesity, with body weight decreasing from an average of 136.6 kg to 87.4 kg over 52 weeks (P < .001).

After VSG, adolescents showed a reduced willingness to exert effort for high-calorie candies, indicating a decreased reward value for these foods, which may contribute to long-term weight loss and maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vertical sleeve gastrectomy in adolescents reduces the appetitive reward value of a sweet and fatty reinforcer in a progressive ratio task. Abdeen, GN., Miras, AD., Alqahtani, AR., et al.[2021]

In a study of 772 patients undergoing vertical sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB), several independent predictors of severe complications were identified, including male gender, open and revisional surgery, hypertension, and hypoalbuminemia.

Hypoalbuminemia was particularly linked to deep surgical site infections and leaks, while open surgery was associated with both superficial and deep infections as well as respiratory complications, highlighting the importance of recognizing these risk factors to improve surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for early postoperative complications after bariatric surgery. Husain, F., Jeong, IH., Spight, D., et al.[2022]

In a study of 1136 patients who underwent sleeve gastrectomy, the methylene blue test (MBT) demonstrated high specificity (98%) and negative predictive value (99%), making it a reliable method to rule out postoperative leaks.

Despite its high specificity, MBT had low sensitivity (22%) and only identified 2 out of 9 actual leaks, indicating that while it is effective for ruling out leaks, it may not be sufficient for confirming their presence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THE ROUTINE USE OF THE METHYLENE BLUE TEST IN SLEEVE GASTRECTOMY: WHY NOT? Ferraz, ÁAB., Santa-Cruz, F., Belfort, JV., et al.[2022]

Vertical sleeve gastrectomy (VSG) in obese rats led to significant and sustained weight loss and fat reduction, indicating its effectiveness as a surgical intervention for obesity.

The study found that the maintenance of weight loss after VSG was not due to improved sensitivity to leptin, suggesting that other mechanisms are responsible for the long-term effects of the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeve gastrectomy induces loss of weight and fat mass in obese rats, but does not affect leptin sensitivity. Stefater, MA., Pérez-Tilve, D., Chambers, AP., et al.[2022]

In a study of over 513,000 patients who underwent vertical sleeve gastrectomy (VSG), staple-line reinforcement (SLR) methods like buttressing (BR) and oversewing (OS) were found to significantly reduce the rates of overall and major bleeding compared to no reinforcement (NR), although they resulted in longer operative times and hospital stays.

No SLR method significantly reduced the incidence of leaks, but bleeding was linked to a higher occurrence of leaks and increased morbidity and mortality, suggesting that using SLR techniques could improve patient outcomes after VSG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Battle of the buttress: 5-year propensity-matched analysis of staple-line reinforcement techniques from the MBSAQIP database. Aboueisha, MA., Freeman, M., Allotey, JK., et al.[2023]

Laparoscopic sleeve gastrectomy (LSG) is a safe and effective bariatric surgery for morbid obesity, with a low overall complication rate of 3.7% for staple line leaks and 2.38% for intraabdominal bleeding among 294 patients studied from 2003 to 2009.

The study highlights the importance of understanding and managing potential complications, as all reoperations were successfully performed laparoscopically, resulting in a global mortality rate of 0%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisional surgery after sleeve gastrectomy. Lacy, A., Ibarzabal, A., Pando, E., et al.[2022]

In a study of 200 patients, laparoscopic vertical sleeve gastrectomy (VSG) was found to have a shorter operative time and hospital stay compared to single-stage laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS).

However, while VSG is technically simpler and has promising outcomes, BPD/DS resulted in significantly greater excess weight loss at 6 months post-surgery, indicating it may be more effective for long-term weight management in morbidly obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of vertical sleeve gastrectomy versus biliopancreatic diversion. Sucandy, I., Titano, J., Bonanni, F., et al.[2021]

In a 2-year study of 66 adolescents and young adults undergoing vertical sleeve gastrectomy (VSG), patients experienced significant weight loss of 25.3%, but also a concerning 8.5% decline in total hip bone mineral density (BMD), indicating potential negative effects on bone health.

The study found that VSG led to a decrease in volumetric BMD at the distal radius and tibia, primarily due to loss of trabecular bone, which may increase the risk of skeletal fragility in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skeletal Effects of Sleeve Gastrectomy in Adolescents and Young Adults: A 2-Year Longitudinal Study. Mitchell, DM., Singhal, V., Animashaun, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5406732/

Five-year outcomes of laparoscopic sleeve gastrectomy as ... In this study, a standardized LSG proved to be safe (no mortality and a leakage rate of 1.2%) and highly effective in terms of weight loss after 5-year of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9638191/

Ten-Year Results of Laparoscopic Sleeve Gastrectomy Mean percentage of excess weight loss (%EWL) at 10 years was 42.65 ± 36.02% and mean percentage of total weight loss was 19.33 ± 16.73%. Twenty- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1015958424012697

Comparing long-term outcomes between laparoscopic ... The aim of this study is to compare the degree of long-term weight loss, remission of co-morbidities and complication rates following LRYGB and LSG procedures.

4. jamanetwork.com jamanetwork.com/journals/jamasurgery/article-abstract/2830466

Long-Term Outcomes of Laparoscopic Roux-en-Y Gastric ... Meaning Over more than 10 years of follow-up, RYGB demonstrated superiority over SG for patient excess body mass index loss. Abstract.

5. asmbs.org asmbs.org/patients/bariatric-surgery-procedures/

Bariatric Surgery Procedures Highly effective for long-term weight loss and remission of type 2 diabetes · Simpler and faster to perform (one intestinal connection) than gastric bypass or ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7154321/

Laparoscopic vertical sleeve gastrectomy, long and short- ... The laparoscopic vertical sleeve gastrectomy (LVSG) has become the most popular operation for the treatment of morbid obesity in the United States.

7. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2784823

Safety of Sleeve Gastrectomy and Gastric Bypass After ... Sleeve gastrectomy was associated with a lower risk of mortality, complications, and overall reintervention 5 years after surgery.

8. mayoclinic.org mayoclinic.org/tests-procedures/sleeve-gastrectomy/about/pac-20385183

Sleeve gastrectomy Sleeve gastrectomy is done to help you lose excess weight and reduce your risk of possibly life-threatening weight-related health problems, ...