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

Trial Summary

What is the purpose of this trial?

It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these questions.

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 data supports the effectiveness of the treatment Gastric Sleeve/Bariatric Surgery, Sleeve Gastrectomy, Vertical Sleeve Gastrectomy, VSG Surgery, Laparoscopic Sleeve Gastrectomy for obesity?

Research shows that vertical sleeve gastrectomy (VSG) leads to significant and sustained weight loss, improves metabolic health, and is considered a safe and effective option for treating obesity. It is also noted for its technical simplicity and promising outcomes compared to more complex surgeries. ^{1 2 3 4 5}

Is weight loss surgery, like sleeve gastrectomy, generally safe for humans?

Weight loss surgery, such as sleeve gastrectomy, is generally considered safe, but there are risks of complications like bleeding, leaks, and effects on bone health. These complications are not common, but they can happen and may require additional treatment. ^{5 6 7 8 9}

How is gastric sleeve surgery different from other obesity treatments?

Gastric sleeve surgery is unique because it involves removing a large portion of the stomach, which not only reduces the amount of food you can eat but also decreases the reward value of high-calorie foods, making it easier to maintain weight loss. It is simpler and safer compared to more complex surgeries, and it is effective as a stand-alone procedure for weight loss. ^{3 4 5 10 11}

Research Team

Michael D Jensen, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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]

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]

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]

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]

References

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

Five-Year Outcomes After Vertical Sleeve Gastrectomy for Severe Obesity: A Prospective Cohort Study. [2018]

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

Sleeve gastrectomy induces loss of weight and fat mass in obese rats, but does not affect leptin sensitivity. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Comparison of vertical sleeve gastrectomy versus biliopancreatic diversion. [2021]

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

Laparoscopic Vertical Sleeve Gastrectomy. [2021]

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

Skeletal Effects of Sleeve Gastrectomy in Adolescents and Young Adults: A 2-Year Longitudinal Study. [2023]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Risk factors for early postoperative complications after bariatric surgery. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Battle of the buttress: 5-year propensity-matched analysis of staple-line reinforcement techniques from the MBSAQIP database. [2023]

8. Brazil pubmed.ncbi.nlm.nih.gov

THE ROUTINE USE OF THE METHYLENE BLUE TEST IN SLEEVE GASTRECTOMY: WHY NOT? [2022]

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

Revisional surgery after sleeve gastrectomy. [2022]

10. United States 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. [2021]

11. United States 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. [2021]