Gastric Bypass Surgery for Obesity

Overseen By Sarah Brown, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Age less than 18, others

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

Compensation: Varies

Number of Visits: 13

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates different approaches to gastric bypass surgery, a weight loss procedure, to understand how surgical variations affect outcomes. Participants will be divided into groups experiencing different techniques, with some undergoing a traditional gastric bypass and others having variations in the surgery's design, such as different BP limb lengths (50 cm, 100 cm, or 150 cm). The trial aims to understand changes in metabolism and gut health resulting from these surgeries, potentially leading to better, personalized obesity treatments. Individuals with a body mass index (BMI) between 40 and 60 who plan to have a gastric bypass might be a good fit. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future obesity treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that different lengths of the biliopancreatic (BP) limb in gastric bypass surgery have been studied for safety and effectiveness.

For the 150 cm BP limb length, studies have found it safe and effective. This length supports good weight loss and improves obesity-related conditions without causing major nutritional problems, which can be a concern with longer limb lengths.

The 100 cm BP limb length is also considered safe. It is often used as a standard in surgeries and is associated with positive weight loss and health outcomes without significant side effects.

Research suggests that the 50 cm BP limb length is safe as well. This shorter length is commonly used and proves effective without causing major health issues.

Overall, these different BP limb lengths in gastric bypass surgery are well-tolerated, and studies support their safety in patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different limb lengths in gastric bypass surgery for obesity, which could lead to more tailored and effective treatments. Unlike the standard approach, which often uses a one-size-fits-all limb length, this trial examines the effects of 50 cm, 100 cm, and 150 cm BP limb lengths. By comparing these variations, the trial seeks to determine the optimal limb length for maximizing weight loss and improving metabolic outcomes. This could potentially revolutionize how gastric bypass surgeries are customized for individual patients.

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

This trial will compare different lengths of the biliopancreatic limb (BPL) in gastric bypass surgery to assess their impact on weight loss. Participants will be assigned to one of three groups: a 150 cm BPL, a 100 cm BPL, or a 50 cm BPL. Research has shown that a 150 cm BPL can lead to effective weight loss, similar to longer lengths, but it might also cause some nutritional deficiencies. Evidence suggests that a 100 cm BPL can result in significant weight loss, often more than shorter lengths. Studies on a 50 cm BPL have found that different lengths do not greatly change the percentage of weight lost. Overall, the effectiveness of each BPL length varies, with longer limbs tending to offer better weight loss but potentially requiring more attention to nutrition. ^{2 4 6 7 8}

Who Is on the Research Team?

Andrew Wheeler, MD

Principal Investigator

University of Missouri-Columbia, Department of Surgery

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe obesity (BMI of 40-60 kg/m2) who are planning to undergo laparoscopic Roux-en-Y gastric bypass surgery and meet their insurance's criteria for weight loss surgery coverage. Participants must be willing to have blood tests, provide stool samples before and after the operation, and attend required follow-ups.

Inclusion Criteria

I am willing to provide blood and stool samples before and after my surgery at specific times.

I am scheduled for a laparoscopic Roux-en-Y gastric bypass surgery.

I am older than 18 years.

Exclusion Criteria

I am under 18 years old.

I am not willing to be randomly assigned to a surgery type or to provide blood and stool samples.

Patient fails to fulfill insurance mandated criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo gastric bypass surgery with variable lengths of bypassed intestine or sleeve gastrectomy, and non-surgical control group receives best medical therapy

12 months

Pre-treatment, 6 months, and 12 months post-treatment visits

Follow-up

Participants are monitored for weight loss, metabolic changes, and complications such as malabsorption and nutrient deficiencies

7 years

Regular follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months, then annually

Sample Collection and Analysis

Collection and analysis of blood and stool samples to measure gut hormones, miRNA, and gut microbiome changes

12 months

Sample collection at pre-treatment, 6 months, and 12 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• 100 cm BP limb length
• 150 cm BP limb length
• 50 cm BP limb length

Trial Overview The study is testing how different lengths of intestine bypass (50 cm, 100 cm, or 150 cm) during gastric bypass surgery affect weight loss outcomes. It will also compare these surgeries with a sleeve gastrectomy group and a non-surgical therapy group while examining gut microbiome changes and hormone levels.

How Is the Trial Designed?

Group I: Standard BP limb length Experimental Treatment 1 Intervention

50 cm BP limb length

Group II: Medium BP limb length Experimental Treatment 1 Intervention

100 cm BP limb length

Group III: Long BP limb length Experimental Treatment 1 Intervention

150 cm BP limb length

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11349854/

The Impact of Longer Biliopancreatic Limb Length ... Long BPL was defined as BPL ≥ 100 cm and short BPL as BPL < 100 cm. The primary outcome was achieving at least 25% total weight loss (TWL) at 5 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4743521/

ROUX-EN-Y GASTRIC BYPASS: LIMB LENGTH AND ... Different lengths of the biliopancreatic and alimentary limbs did not affect the percentage of total weight loss.

3. nature.com nature.com/articles/s41366-022-01186-0

Length of biliopancreatic limb in Roux-en-Y gastric bypass ... This aim of this systematic review and meta-analysis was to determine whether biliopancreatic limb (BPL) length in RYGB affects postoperative outcomes.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0011384024001230

Efficacy and safety of long vs short biliopancreatic limb in ... We conclude that a Long biliopancreatic limb is significantly better than a short biliopancreatic limb in a Roux-en-y gastric bypass surgery when it comes to ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05313-6

Different limb lengths in gastric bypass surgery: study protocol ... This article describes the design and protocol of a randomized controlled trial comparing the outcome of a RYGB operation with a long versus short BPL.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7233152/

The role of alimentary and biliopancreatic limb length in ... There was no significant relationship between the length of BPL and AL and weight loss outcomes over short-term follow-up (12 months); however, the patients ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7154326/

Laparoscopic Roux en Y gastric bypass in the super obese The authors routinely use a biliopancreatic limb length of 100cm and extend this to 150–180 cm where greater effect is felt clinically indicated—for example ...

8. link.springer.com link.springer.com/article/10.1007/s11695-024-07267-5

A Population-Based Matched Cohort Study | Obesity Surgery The biliopancreatic limb (BPL) is thought to play an important role in achieving weight loss and associated comorbidity resolution.