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.
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.
+2 more
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
+1 more
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Missouri-ColumbiaColumbia, MO
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Who Is Running the Clinical Trial?
University of Missouri-ColumbiaLead Sponsor