Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach

Enrolling by invitation · Not applicable

Conditions studied: Obesity, Morbid, Metabolic Syndrome, NASH - Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT04841057

Run by

University of Missouri-Columbia

People needed

750

Starts

2021-11-01

Expected to finish

2031-03-01

Last updated by the study team

2025-08-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age greater than 18
• Body mass index of 40-60 kg/m2
• Meet insurance criteria, as set forth by the patient's insurance policy, to qualify for coverage for weight loss surgery
• Planned laparoscopic Roux-en-Y gastric bypass
• Willingness to have blood collected before and after surgical procedure at defined points and collect and mail stool sample before operation and at defined post-operative time points.

You may not qualify if…

• Age less than 18
• Patient fails to fulfill insurance mandated criteria
• Unwilling to be randomized to variable length to gastric bypass or unwilling to have blood collected or personally collect and mail in stool sample
• Unwilling to follow-up at required postoperative visits

Where it is running

• University of Missouri-Columbia — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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