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

750 Participants Needed

Trial Summary

What is the purpose of this trial?

Variable outcomes after weight loss surgery are likely attributable to complex, poorly understood mechanisms. Due to the significant impact that morbid obesity has on a patient's health, successful management of obesity and its related comorbid medical conditions is important and thus necessitates continued improved therapies for treating obesity. Although the mechanisms of weight loss after surgical intervention are poorly understood, improved understanding of molecular and metabolic changes that occur after weight loss surgery may offer the ability to provide targeted precision therapy for patients with morbid obesity undergoing surgical therapy. In this proposal, the investigators will combine a clinical trial whereby modifications to the gold-standard for weight loss surgery, the gastric bypass, are evaluated while simultaneously measuring molecular and metabolic changes that occur in response to these weight loss procedures. Through creating variable lengths of bypass intestine after gastric bypass, the investigators will be able to determine the effect of malabsorption on clinical outcomes and mechanisms involved in weight loss after gastric bypass. The investigators will also use two control groups. One will be a surgical weight loss control group and consist of patients undergoing a laparoscopic sleeve gastrectomy, a non-intestinal bypass procedure. The other group will consist of patients having non-surgical weight loss therapy. To asses metabolic changes that occur in response to surgical weight therapy and specifically intestinal bypass and malabsorption, the investigators will examine changes in the gut microbiome and plasma gut enteroendocrine hormones. To evaluate molecular pathways that are impacted as a result of gastric bypass and malabsorption, the investigators will measure circulating microRNAs (miRNAs) in the blood. Measurement of miRNAs will provide data on an easily measurable molecular marker for each treatment group. This is a first step in translational exploration of mechanisms of weight loss after surgery by evaluating both clinical and molecular/metabolic outcomes and begin an explorative process towards creating an individualized approach to improving outcomes after weight loss surgery.

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.

What data supports the effectiveness of the treatment involving different BP limb lengths in gastric bypass surgery for obesity?

Research suggests that longer limb lengths in gastric bypass surgery may offer a modest weight loss advantage for superobese patients (those with a very high BMI), but not for those who are morbidly obese. Longer limb lengths did not show significant nutritional side effects. ^{1 2 3 4 5}

Is gastric bypass surgery generally safe for humans?

Gastric bypass surgery, including variations with different limb lengths, is generally considered safe for treating obesity. Studies have shown no unique nutritional side effects for longer limb lengths, and adjustments in limb length may help reduce nutritional complications without affecting weight loss. ^{2 3 5 6 7}

How does the gastric bypass surgery with different BP limb lengths differ from other treatments for obesity?

This gastric bypass surgery is unique because it involves varying the length of the biliopancreatic (BP) limb, which can be tailored to the patient's body weight. Longer BP limb lengths, such as 100 cm or 150 cm, may offer better weight loss outcomes for super-obese patients compared to shorter limb lengths, without causing additional nutritional complications. ^{2 3 5 7 8}

Research Team

Andrew Wheeler, MD

Principal Investigator

University of Missouri-Columbia, Department of Surgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Gastric bypass with long alimentary limb or long pancreato-biliary limb--long-term results on weight loss, resolution of co-morbidities and metabolic parameters. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic Roux-en-Y gastric bypass in patients with BMI [2010]

4. United States pubmed.ncbi.nlm.nih.gov

The importance of the length of the limbs for gastric bypass patients--an evidence-based review. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Long- or short-limb gastric bypass? [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Outcomes of the One Anastomosis Gastric Bypass with Various Biliopancreatic Limb Lengths: a Retrospective Single-Center Cohort Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

150-cm Versus 200-cm Biliopancreatic Limb One-Anastomosis Gastric Bypass: Propensity Score-Matched Analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic mini-gastric bypass: experience with tailored bypass limb according to body weight. [2018]