Metabolic & Bariatric Surgery for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how weight-loss surgery affects fat metabolism, the immune system, and possibly cancer development. It involves women with severe obesity who either plan to undergo or have already undergone Roux-en-Y gastric bypass surgery. Researchers aim to determine how surgery changes fat levels in the blood and certain immune cells that might affect cancer risk. Women who might be suitable candidates have severe obesity and high cholesterol but do not have diabetes or a history of cancer.
As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance understanding of obesity-related health risks.
Will I have to stop taking my current medications?
You may need to stop taking certain medications. If you are using anti-inflammatory drugs or medications for obesity management, you must stop them at least 15 days before joining the trial.
What prior data suggests that metabolic surgery is safe for patients with class III obesity?
Research has shown that Roux-en-Y gastric bypass surgery, the treatment under study, is generally effective for significant weight loss and improving health issues related to obesity. Studies indicate that it can lead to long-term weight loss and high rates of improvement for conditions often linked to obesity. However, this surgery can have more complications compared to some other weight-loss surgeries.
While the surgery is considered safe for many people, it does carry some risks, as with any surgery. These risks include infections, bleeding, or problems related to anesthesia. This procedure has been used for years as a standard treatment for severe obesity, supporting its overall safety. Anyone considering this surgery should consult with their healthcare provider to discuss these potential risks and determine if it's the right choice.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how Roux-en-Y metabolic and bariatric surgery can impact lipid metabolism and cancer cell biology in women with class III obesity. Unlike other treatments that primarily focus on weight loss as the main outcome, this surgery may offer additional benefits by altering the body's lipid metabolism, which could influence cancer risk. By examining both pre- and post-operative changes in immune cells and cancer-related markers, the study aims to uncover new insights into how metabolic surgery might contribute to broader health improvements beyond just weight reduction.
What evidence suggests that Roux-en-Y metabolic and bariatric surgery is effective for class III obesity?
This trial will compare two cohorts of women with class III obesity undergoing Roux-en-Y gastric bypass surgery. Research has shown that Roux-en-Y gastric bypass surgery effectively results in significant weight loss for individuals with severe obesity. Studies indicate that this surgery helps maintain most of the weight loss for up to 20 years. It also effectively puts type 2 diabetes into remission, which can last up to 15 years. Additionally, it addresses other health issues like high blood pressure and cholesterol. Overall, this surgery is a strong option for managing severe obesity and related health conditions.35678
Who Is on the Research Team?
Justin Brown, Ph.D.
Principal Investigator
Pennington Biomedical Research Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Participants in Cohort 1 undergo preoperative study measures
Surgery and Immediate Recovery
Participants undergo Roux-en-Y metabolic and bariatric surgery
Postoperative Follow-up
Participants in Cohort 1 complete study measures one year postoperatively
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Metabolic & Bariatric Surgery
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Cohort #2 (between-subject) will enroll up to 10 women with a history of class III obesity who underwent Roux-en-Y metabolic and bariatric surgery as a standard of obesity care approximately one year before enrollment. Subjects in this cohort will be matched on demographic and clinical variables to those in Cohort #1.
Cohort #1 (within-subject) will enroll up to 10 women with class III obesity who plan to undergo Roux-en-Y metabolic and bariatric surgery as a standard of obesity care. Subjects will complete study measures preoperatively and one year postoperatively.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pennington Biomedical Research Center
Lead Sponsor
Citations
Outcomes After Laparoscopic Roux-en-Y Gastric Bypass for ...
Roux-en-Y gastric bypass (RYGBP) has been shown to produce significant weight loss in patients with clinically severe obesity: most studies report a weight loss ...
Ten-Year Outcomes Following Roux-en-Y Gastric Bypass ...
At follow-up, the mean BMI reductions were 11.0 (95% CI, 8.3-13.7) for RYGB and 20.3 (95% CI, 17.6-23.0) for DS, with a mean between-group ...
New Study Shows Long-term Effectiveness of Gastric ...
Roux-en-Y gastric bypass, a type of weight-loss surgery, kept type 2 diabetes in remission for up to 15 years and most of the weight off for up to 20 years.
Weight and Metabolic Outcomes 12 Years after Gastric ...
This study showed long-term durability of weight loss and effective remission and prevention of type 2 diabetes, hypertension, and dyslipidemia after Roux-en-Y ...
Roux-en-Y gastric bypass, adjustable gastric banding, or ...
Metabolic and bariatric surgery can lead to 20–30% total weight loss. Trials show that obesity management medications can lead to reductions of ...
Roux-en-Y Gastric Bypass - StatPearls - NCBI Bookshelf
Results from long-term studies show sustained weight loss and high remission rates for these comorbidities, making RYGB an effective intervention for obesity.
Comprehensive outcomes after Roux-en-Y gastric bypass ...
Laparoscopic Roux-en-Y gastric bypass provides sustainable weight loss over a 15-year period, with consistent long-term weight-loss outcomes and resolution of ...
Safety and Effectiveness of Gastric Bypass and Sleeve ...
Many publications, including those from the PCORnet Bariatric Study, have shown higher rates of complications with RYGB when compared with SG.
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