Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach

NCT04841057 | Enrolling By Invitation DMC

• 1 other identifier: 2032062
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gastric bypass; intestinal bypass; gut microbiome; microRNA; enteroendocrine hormones; weight recidivism; biliopancreatic limb

Outcome Measures

Primary Outcomes (2)

• Weight loss after Variable Biliopancreatic Limb Length Bypass

  Evaluation of weight loss after modifications to the length of BP limb length

  7 years

• Complications after Variable Biliopancreatic Limb Length Bypass

  Evaluation of weight loss after modifications to the length of BP limb length

  7 years

Secondary Outcomes (3)

• MicroRNA expression after Variable Biliopancreatic Limb Length Bypass

  7 years

• Gut microbiome changes after Variable Biliopancreatic Limb Length Bypass

  7 years

• Gut enteroendocrine changes after Variable Biliopancreatic Limb Length Bypass

  7 years

Study Arms (3)

Standard BP limb length

EXPERIMENTAL

50 cm BP limb length

Procedure: 50 cm BP limb length

Medium BP limb length

EXPERIMENTAL

100 cm BP limb length

Procedure: 100 cm BP limb length

Long BP limb length

EXPERIMENTAL

150 cm BP limb length

Procedure: 150 cm BP limb length

Interventions

50 cm BP limb length PROCEDURE

50 cm biliopancreatic limb length

Standard BP limb length

100 cm BP limb length PROCEDURE

100 cm biliopancreatic limb length

Medium BP limb length

150 cm BP limb length PROCEDURE

150 cm BP limb length

Long BP limb length

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65203, United States

Location

MeSH Terms

Conditions

Obesity, Morbid; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Andrew Wheeler, MD

  University of Missouri-Columbia, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinded to participant at time of surgery. Randomization during operation
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: Patients undergoing gastric bypass

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will only be made available on a case by case data and provided in a deidentified manner
• Access Criteria: Data must be deidentified and data must be requested from the PI listed

Locations

US (1)