Weight Loss Surgery for Obesity
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Beta blockers, Corticosteroids
Disqualifiers: Diabetes, Coronary artery disease, Smoking, others
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
56789How 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.
3451011Eligibility 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.
+5 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Gastric sleeve surgeryExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Five-Year Outcomes After Vertical Sleeve Gastrectomy for Severe Obesity: A Prospective Cohort Study. [2018]We present 5-year outcomes after vertical sleeve gastrectomy (VSG), including complications and revisions, weight change, obesity-related diseases and health-related quality of life (HRQOL).
Sleeve gastrectomy induces loss of weight and fat mass in obese rats, but does not affect leptin sensitivity. [2022]Surgical intervention produces sustainable weight loss and metabolic improvement in obese individuals. Vertical sleeve gastrectomy (VSG) produces dramatic, sustained weight loss; we investigated whether these changes result from improved sensitivity to leptin.
Comparison of vertical sleeve gastrectomy versus biliopancreatic diversion. [2021]Vertical sleeve gastrectomy (VSG) was originally performed as the first-stage of biliopancreatic diversion with duodenal switch (BPD/DS) for superobesity as a strategy to reduce perioperative complications and morbidity. VSG is now considered a definitive procedure because of its technical simplicity and promising outcomes.
Laparoscopic Vertical Sleeve Gastrectomy. [2021]Bariatric surgery has emerged as the most effective means of achieving weight loss. Obesity surgery is a quickly expanding field. Laparoscopic vertical sleeve gastrectomy is a great option for patients because it is simple, exceedingly safe, has a fairly defined postoperative complication profile, and is as effective as more complex bariatric surgery options. Specific consideration of patients' comorbidities, assessment of surgeon's skill, and knowledge of preoperative, perioperative, and postoperative course is a must for all surgeons who wish to perform this procedure. If properly used, vertical sleeve gastrectomy is a powerful tool in combating obesity and its deleterious effects.
Skeletal Effects of Sleeve Gastrectomy in Adolescents and Young Adults: A 2-Year Longitudinal Study. [2023]Vertical sleeve gastrectomy (VSG) is an increasingly common tool to achieve weight loss and improve metabolic health in adolescents and young adults with obesity, although it may adversely affect bone health.
Risk factors for early postoperative complications after bariatric surgery. [2022]Vertical sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are currently the most common bariatric procedures. Although the safety of these operations has markedly improved, there continues to be a certain rate of complications. Such adverse events can have a significant deleterious effect on the outcome of these procedures and represent a costly burden on patients and society at large. A better understanding of these complications and their predictive factors may help ameliorate and optimize outcomes.
Battle of the buttress: 5-year propensity-matched analysis of staple-line reinforcement techniques from the MBSAQIP database. [2023]Vertical sleeve gastrectomy (VSG) has demonstrated to be safe; however, controversy remains on how to decrease major complications, particularly bleeding and leaks. There are variations in staple-line reinforcement techniques, including no reinforcement, oversewing, and buttressing. We sought to evaluate the effect of those methods on post-operative complications using the Metabolic and Bariatric Surgery Accreditation Quality Initiative Program (MBSAQIP) database.
THE ROUTINE USE OF THE METHYLENE BLUE TEST IN SLEEVE GASTRECTOMY: WHY NOT? [2022]Although considered a safe procedure, sleeve gastrectomy (SG) has a non-negligible risk of major postoperative complications related to it, with special attention to gastric leaks.
Revisional surgery after sleeve gastrectomy. [2022]Worldwide, morbid obesity incidence has increased dramatically in the last decade and surgery is at this moment recognized as the only effective treatment with long-term sustained weight loss and resolution or significant improvement in comorbidities. Laparoscopic sleeve gastrectomy (LSG) was successfully carried out by several groups as a bridge to future laparoscopic bariatric procedures with acceptable weight loss and reduction in comorbidities. LSG is considered a safe procedure with sporadically reported complications, such as bleeding or leakage from the staple line, strictures, delayed gastric emptying, gastric dilatation and vomiting. The aim of this publication is to describe complications of this procedure analyze different treatments of these events especially the surgical ones, reporting the technical management based on our experience and on the literature.
Laparoscopic sleeve gastrectomy is a safe and effective bariatric procedure for the lower BMI (35.0-43.0 kg/m2) population. [2021]The laparoscopic vertical sleeve gastrectomy (LSG) is derived from the biliopancreatic diversion with duodenal switch operation (Marceau et al., Obes Surg 3:29-35, 1993; Hess and Hess, Obes Surg 8:267-82, 1998; Chu et al., Surg Endosc 16:S069, 2002). Later, LSG was advocated as the first step of a two-stage procedure for super-obese patients (Regan et al., Obes Surg 13:861-4, 2003; Cottam et al., Surg Endosc 20:859-63, 2006). However, recent support is mounting that continues to establish LSG as the definitive procedure for surgical treatment of morbid obesity. We will report our experience with the LSG as a primary bariatric procedure and evaluate if this operation is suitable as a stand-alone procedure.
Vertical sleeve gastrectomy in adolescents reduces the appetitive reward value of a sweet and fatty reinforcer in a progressive ratio task. [2021]Adolescent obesity is challenging to treat even if good multidisciplinary approaches are started early. Vertical sleeve gastrectomy (VSG) is an effective intervention for long-term weight loss, but the underlying mechanisms that result in reduced calorie intake are controversial. Anecdotal evidence from the clinic and evidence in rodents after VSG suggest a decrease in the reward value of high-calorie dense foods.