Biological Sample Collection for Obesity

Overseen By Michele B. Ryan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pichamol Jirapinyo, MD, MPH

Must not be taking: Obesity medications

Disqualifiers: HIV, Celiac disease, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather biological samples from individuals with obesity to better understand how different treatments affect weight loss and regain. Participants will include those undergoing medical management, endoscopic therapies, or bariatric surgery. The study seeks to identify why some people successfully lose weight while others do not and to find potential new targets for treatment. Individuals with a BMI of 30 or higher who have not experienced recent severe health issues may be suitable for this study. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to new treatment options for obesity.

Will I have to stop taking my current medications?

The trial requires that you do not use any medications, including prescription, over-the-counter, herbal, or other supplements, for the treatment of obesity.

What prior data suggests that the biological sample collection is safe for participants?

A previous study found that weight-loss surgeries like Roux-en-Y gastric bypass and sleeve gastrectomy are generally safe. These surgeries have been performed for many years and are usually well-tolerated. Common side effects include nausea and digestive issues, but serious problems are rare.

Research has shown that endoscopic therapies are also safe. Procedures such as placing intragastric balloons and performing endoscopic sleeve gastroplasty have a good safety record. Most patients do not experience severe side effects, though some may feel temporary discomfort or nausea.

For medical management, which includes lifestyle changes and medications, studies indicate safety as well. Common weight-loss medications have been tested and usually cause mild side effects, like dry mouth or dizziness, but serious issues are uncommon.

Overall, each treatment has a proven safety record with known and manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance our understanding of obesity treatment outcomes by gathering biological samples from different intervention groups. This trial is unique because it includes participants who have undergone various types of bariatric surgery, endoscopic bariatric therapies, and those managing obesity through medical means like lifestyle changes or medications. By comparing biological samples across these diverse approaches, researchers hope to uncover insights into how these treatments affect metabolic and physiological processes, potentially leading to more personalized and effective obesity treatments in the future.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will collect biological samples from participants undergoing various obesity treatments. Research has shown that weight loss surgeries, such as gastric bypass and sleeve gastrectomy, effectively aid people with severe obesity. Studies have found that these surgeries can lead to significant weight loss, although results vary among individuals. Participants in this trial may have undergone such surgeries.

For less invasive options, endoscopic treatments like endoscopic sleeve gastroplasty and intragastric balloons have shown promising results. One study reported an average weight loss of about 15.2% after 6 months and 18.6% after 24 months. Participants in this trial may have received these endoscopic treatments.

Regarding medication, drugs like GLP-1 agonists have been shown to help people lose between 8% to 12% of their weight in real-world settings. Participants in this trial may also follow medical management strategies, including lifestyle modifications and anti-obesity medications. Overall, these treatments effectively aid weight loss, but results can differ depending on the individual and the method used. ^{1 3 4 6 7}

Who Is on the Research Team?

Pichamol Jirapinyo, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Suffer from obesity, defined by BMI≥30 kg/m2 (body mass index: weight in kilograms divided by the square of the height in meters).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Collection of blood, urine, and tissue samples from participants for repository

Ongoing

Scheduled endoscopic examination for tissue collection

Follow-up

Participants are monitored for safety and effectiveness after sample collection

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Biological Sample Repository

How Is the Trial Designed?

Group I: Medical Management Experimental Treatment 3 Interventions

Subjects who follow lifestyle modification and/or anti-obesity medications for treatment of obesity with no previous surgical intervention for obesity. Medical therapies include weight loss diets or anti-obesity medications.

Group II: Endoscopic Metabolic and Bariatric Therapies Experimental Treatment 3 Interventions

Subjects who have had endoscopic bariatric therapies for obesity - primary and revision. Bariatric endoscopic procedures include ablation techniques, intragastric balloons, submucosal tunneling procedures (PSAM, GEM, G-POEM), tissue plication platforms (POSE, ROSE), endoluminal sleeves and endoscopic suturing devices (ESG).

Group III: Bariatric Surgery Patients Experimental Treatment 3 Interventions

Subjects who have had bariatric surgery for obesity - primary and revision. Bariatric surgical procedures include laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB), bilio-pancreatic diversion (BPD) with or without duodenal switch (BPD-DS).

Who Is Running the Clinical Trial?

Pichamol Jirapinyo, MD, MPH

Lead Sponsor

Trials

2

Recruited

600+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Tufts University

Collaborator

Trials

271

Recruited

595,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23769112/

sleeve gastrectomy or Roux-en-Y gastric bypass? The aim of our study is to evaluate and compare the safety and efficacy of converting LAGB to laparoscopic sleeve gastrectomy (LSG) versus laparoscopic Roux-en- ...

2. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(25)00025-7/fulltext

Roux-en-Y gastric bypass, adjustable gastric banding, or ... Results from the By-Band-Sleeve study show that for patients with severe obesity referred for metabolic and bariatric surgery according to UK ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1743919119302018

Effectiveness of laparoscopic Roux-en-Y gastric bypass ... Effectiveness of laparoscopic Roux-en-Y gastric bypass and sleeve gastrectomy for morbid obesity in achieving weight loss outcomes. Author links open overlay ...

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

Bariatric Surgery Procedures The goal of these operations is to modify the stomach and intestines to treat obesity and related diseases.

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2669728

Effect of Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass ... This study did not find a significant difference in weight loss between sleeve gastrectomy and gastric bypass.

6. journals.physiology.org journals.physiology.org/doi/full/10.1152/ajpregu.00038.2011

Roux-en-Y gastric bypass and laparoscopic sleeve ... Here we review mechanisms of weight loss and T2D resolution after Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy bariatric surgery, two markedly ...

7. cms.gov cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=160&NcaName=Bariatric+Surgery+for+the+Treatment+of+Morbid+Obesity+%281st+Recon%29&bc=ACAAAAAAEAAA&

Bariatric Surgery for the Treatment of Morbid Obesity Use this page to view details for the decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R).