Bariatric Surgery for Obesity
Recruiting in Palo Alto (17 mi)
Overseen BySharon L Wardlaw, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Must not be taking: Diabetes meds, Beta-blockers
Disqualifiers: Tobacco, Alcohol, Drug abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this project is to understand why bariatric surgery is such an effective treatment for obesity with a focus on brain mechanisms. Cerebrospinal fluid (CSF) neuropeptide, hormone and protein levels will be measured as a surrogate for changes in brain activity in participants before and after bariatric surgery as compared with participants before and after diet-induced weight loss. The investigators are studying neuropeptides and hormones that are know to be involved with the regulation of appetite and body weight to determine if some of the changes that are expected to occur after diet-induced weight loss do not occur after bariatric surgery. In addition, proteomic analysis will be used to uncover new protein biomarkers that are unique to surgical weight loss. The results of these studies will help explain why bariatric surgery is so effective in achieving long-term weight loss. Understanding how the central nervous system responds to bariatric surgery could help the development of alternative nonsurgical therapies for obesity and its metabolic complications.
Will I have to stop taking my current medications?
Yes, you will need to stop taking medications that affect body weight or blood sugar, as well as diabetes medications, beta-blockers, opiates, or glucocorticoids.
What data supports the effectiveness of the treatment Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) for obesity?
Research shows that Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are effective for long-term weight loss and improving obesity-related health issues. RYGB is considered a gold standard for sustained weight loss, and both surgeries lead to hormonal changes that help with diabetes remission and weight loss.
12345Is bariatric surgery generally safe for humans?
Bariatric surgeries like Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are generally considered safe, but they can have complications. These procedures have improved safety over time, but some risks remain, such as gastrointestinal issues and potential complications after surgery.
678910How does the treatment of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) for obesity differ from other treatments?
Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) are surgical treatments for obesity that are considered more effective for long-term weight loss compared to other methods like very low calorie diets. RYGB is often used as a secondary procedure when other surgeries like gastric banding or sleeve gastrectomy do not yield satisfactory results, making it a unique option for patients needing further intervention.
511121314Eligibility Criteria
This trial is for adults aged 18-65 with obesity, having a BMI between 35 and 55. Participants should not be on diabetes medications, beta-blockers, opiates or glucocorticoids; should have stable weight in the past six months; and must not use tobacco or abuse substances. Pregnant or breastfeeding individuals can't join the diet group.Exclusion Criteria
No lactose intolerance
No recent weight change (+/-5%) within prior 6 months
No pregnancy, breastfeeding, or planning to become pregnant during the study (diet group only)
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-Intervention
Participants are assessed before the intervention, including lumbar puncture for CSF sampling and blood collection
1 week
1 visit (in-person)
Post-Surgery/Diet Weight Loss
Participants are assessed after achieving 10-15% weight loss, including lumbar puncture for CSF sampling and blood collection
12 weeks for diet participants, variable for surgery participants
1 visit (in-person)
12-Month Follow-up
Participants are assessed 12 months after surgery, including lumbar puncture for CSF sampling and blood collection
12 months
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study compares brain changes in obese patients undergoing Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG) to those following a Very Low Calorie Diet (VLCD). It measures cerebrospinal fluid to track appetite-regulating hormones before and after these interventions.
3Treatment groups
Active Control
Group I: Roux-en-Y Gastric Bypass SurgeryActive Control1 Intervention
Group II: Sleeve Gastrectomy SurgeryActive Control1 Intervention
Group III: Very Low Calorie DietActive Control1 Intervention
Roux-en-Y Gastric Bypass (RYGB) is already approved in United States, European Union, Canada, Australia for the following indications:
๐บ๐ธ Approved in United States as Roux-en-Y Gastric Bypass for:
- Obesity
- Type 2 Diabetes
- Gastroesophageal Reflux Disease (GERD)
- Sleep Apnea
๐ช๐บ Approved in European Union as Roux-en-Y Gastric Bypass for:
- Obesity
- Type 2 Diabetes
- Hypertension
- Hyperlipidemia
๐จ๐ฆ Approved in Canada as Roux-en-Y Gastric Bypass for:
- Obesity
- Type 2 Diabetes
- Gastroesophageal Reflux Disease (GERD)
- Sleep Apnea
๐ฆ๐บ Approved in Australia as Roux-en-Y Gastric Bypass for:
- Obesity
- Type 2 Diabetes
- Hypertension
- Hyperlipidemia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Medical CenterNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Conversion of Open Vertical Banded Gastroplasty to Roux-en-Y Gastric Bypass: a Single-Center, Single-Surgeon Experience with 6 Years of Follow-up. [2018]The aim of this study is to assess feasibility, relief of complications and mid- and long-term weight loss results following the conversion of open vertical banded gastroplasty (VBG) to Roux-en-Y gastric bypass (RYGB).
Weight loss at six months is the surrogate of long-term treatment outcomes for obese Chinese with a BMI less than 35 kg/m2 undergoing Roux-en-Y gastric bypass. [2022]Roux-en-Y gastric bypass (RYGB) is considered the gold standard procedure for bariatric surgery that leads to sustained weight loss and amelioration of obesity-related comorbidities.
Updates in weight loss surgery and gastrointestinal peptides. [2018]Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy are referred to as 'metabolic surgery' due to hormonal shifts with impacts on diabetes remission and weight loss. The purpose of this review is to summarize recent findings in mechanisms underlying beneficial effects of weight loss surgery.
Primary Roux-en-Y Gastric Bypass Results in Greater Weight Loss at 15-Year Follow-Up Compared with Secondary Roux-en-Y Gastric Bypass After Failure of Gastric Band or Mason McLean Vertical Gastroplasty. [2021]The aim of the study is to compare the outcomes of patients treated with secondary Roux-en-Y gastric bypass (RYGB) after adjustable gastric banding (AGB) or vertical banded gastroplasty (VBG) with those of patients having primary RYGB.
Guiding Patients Toward the Appropriate Surgical Treatment for Obesity: Should Presurgery Psychological Correlates Influence Choice Between Roux-en-Y Gastric Bypass and Vertical Sleeve Gastrectomy? [2018]Helping patients determine which type of bariatric surgery, Roux-en-Y gastric bypass (RYGB) or vertical sleeve gastrectomy (VSG), may be the best treatment can be challenging. This study investigated psychological correlates and their influence on weight loss for patients who underwent RYGB or VSG.
Two-year outcomes of Roux-en-Y gastric bypass vs medical treatment in type 2 diabetes with a body mass index lower than 32.5 kg/m2: a multicenter propensity score-matched analysis. [2022]Roux-en-Y gastric bypass (RYGB) has been widely reported to be safe and feasible, and has a powerful effect on improving metabolism and weight loss in patients with a high body mass index (BMI). A few studies have focused on the comparison of RYGB with medical treatment in type 2 diabetes (T2D) patients with a lower BMI.
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.
Gastrointestinal manifestations after Roux-en-Y gastric bypass surgery in individuals with and without type 2 diabetes. [2021]Roux-en-Y gastric bypass (RYGB) surgery is an effective treatment for obesity, which improves cardiovascular health and reduces the risk of premature mortality. However, some reports have suggested that RYGB may predispose patients to adverse health outcomes, such as inflammatory bowel disease (IBD) and colorectal cancer.
The role of alimentary and biliopancreatic limb length in outcomes of Roux-en-Y gastric bypass. [2022]Roux-en-Y gastric bypass (RYGB) is one of the safe and easily reproducible bariatric procedures.
Is Bariatric Procedure Type Associated With Morbidity in Transplant Patients? [2022]Roux-en-Y Gastric Bypass (RYGB) has been associated with increased weight loss but more complications when compared with sleeve gastrectomy (SG). However, a direct comparison between RYGB and SG has never been performed in patients with a history of solid organ transplantation. The aim of this study was to determine the association between procedure type and surgical outcomes.
Unsatisfactory weight loss after vertical banded gastroplasty: is conversion to Roux-en-Y gastric bypass successful? [2004]In 1991, the National Institutes of Health sanctioned 2 operations for treatment of morbid obesity: vertical banded gastroplasty (VBG) and Roux-en-Y gastric bypass (RYGB). Long-term results with VBG are disappointing. We wondered whether patients who had "adapted" to the VBG anatomy and had regained weight would lose weight after conversion to RYGB.
Conversion to Gastric Bypass After Either Failed Gastric Band or Failed Sleeve Gastrectomy. [2018]Roux-en-Y gastric bypass (RYGB) is still considered the gold standard in bariatric surgery. Before, adjustable gastric banding (AGB) was regarded as an alternative; nowadays, sleeve gastrectomy (SG) is a more favorable alternative. In case of unsatisfactory results, RYGB is often performed as a secondary procedure. Conversion of an AGB is associated with a high risk of complications; the hypothesis was that this would be less after conversion of an SG.
Vitamin D status and supplementation before and after bariatric surgery: a comprehensive literature review. [2018]Bariatric surgery is the most effective long-term weight loss method. The most common procedures are Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG). Bariatric patients are at high risk of vitamin D deficiency (VDD) and insufficiency (VDI), which are associated with skeletal and nonskeletal ailments. There is no consensus regarding the optimal treatment for VDD/VDI in bariatric patients.
Comparison of the long-term results of Roux-en-Y gastric bypass and sleeve gastrectomy for morbid obesity: a systematic review and meta-analysis of randomized and nonrandomized trials. [2018]Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are 2 of the most widely used bariatric procedures today, in this meta-analysis, both techniques were compared for evaluating the efficacy and safety of the treatment of morbid obesity.