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Gastric Bypass Surgery for Obesity

N/A
Waitlist Available
Led By Andrew Wheeler, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned laparoscopic Roux-en-Y gastric bypass
Age greater than 18
Must not have
Age less than 18
Unwilling to follow-up at required postoperative visits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how different modifications to the gastric bypass surgery affect molecular and metabolic changes in the body, in an effort to create targeted therapies for patients with morbid obesity.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include typical risks associated with weight loss surgeries such as nutritional deficiencies due to malabsorption, surgical complications like infections or bleeding, gastrointestinal symptoms like nausea or vomiting, and changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a laparoscopic Roux-en-Y gastric bypass surgery.
Select...
I am older than 18 years.
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My insurance covers weight loss surgery according to its policy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.
Select...
I am not willing to attend all required follow-up visits after surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complications after Variable Biliopancreatic Limb Length Bypass
Weight loss after Variable Biliopancreatic Limb Length Bypass
Secondary study objectives
Gut enteroendocrine changes after Variable Biliopancreatic Limb Length Bypass
Gut microbiome changes after Variable Biliopancreatic Limb Length Bypass
MicroRNA expression after Variable Biliopancreatic Limb Length Bypass

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Standard BP limb lengthExperimental Treatment1 Intervention
50 cm BP limb length
Group II: Medium BP limb lengthExperimental Treatment1 Intervention
100 cm BP limb length
Group III: Long BP limb lengthExperimental Treatment1 Intervention
150 cm BP limb length

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
627,744 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
402 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Andrew Wheeler, MDPrincipal InvestigatorUniversity of Missouri-Columbia, Department of Surgery
2 Previous Clinical Trials
390 Total Patients Enrolled

Media Library

100 cm BP limb length Clinical Trial Eligibility Overview. Trial Name: NCT04841057 — N/A
Non-alcoholic Fatty Liver Disease Research Study Groups: Long BP limb length, Standard BP limb length, Medium BP limb length
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: 100 cm BP limb length Highlights & Side Effects. Trial Name: NCT04841057 — N/A
100 cm BP limb length 2023 Treatment Timeline for Medical Study. Trial Name: NCT04841057 — N/A
~500 spots leftby Mar 2031
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