Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach

Summary

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.

Conditions

• Obesity, Morbid
• Metabolic Syndrome
• NASH - Nonalcoholic Steatohepatitis

Interventions

PROCEDURE

50 cm BP limb length

50 cm biliopancreatic limb length

PROCEDURE

100 cm BP limb length

100 cm biliopancreatic limb length

PROCEDURE

150 cm BP limb length

150 cm BP limb length

Sponsors & Collaborators

• University of Missouri-Columbia

  lead OTHER

Principal Investigators

• Andrew Wheeler, MD · University of Missouri-Columbia, Department of Surgery

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2031-03-01

Completion

2031-03-01

Countries

• United States

Study Locations