Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07178704

The Metabolic and Genetic Drivers of Body Composition Changes Following Weight Loss Surgery

Led by The University of Texas Medical Branch, Galveston · Updated on 2025-11-12

110

Participants Needed

1

Research Sites

90 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Weight loss surgery is very good at reducing body weight but it can also cause the loss of both muscle and strength. Some patients undergoing weight loss surgery do not achieve their weight loss goals and regain the weight they lost. When this occurs, the loss of muscle and strength combined with the regain of weight can impact the individual's quality of life and ability to remain active and mobile. The purpose of this study is to understand the behavioral, biological, and genetic factors that influence the success of weight loss surgery and its impact on muscle mass. Bariatric surgery patients participating in the trial will be monitored prior to, and for a year following weight loss surgery, with data collected about their eating habits, hand grip strength, and the loss of fat, muscle, and body weight following surgery. Some patients will be additionally invited to undergo detailed metabolic assessment, where we will measure how their body uses nutrients it consumes, the composition of their body (e.g. how much lean and fat tissue they have and where it is stored), identify the bacteria living in their gut, and determine their physical performance. In all patients a small sample of gut tissue will be collected at a routine endoscopy performed in advance of weight loss surgery to identify the expression (activity) of genes in their DNA. Healthy subjects will also be recruited to allow us to compare between healthy weight individuals and those undergoing weight loss surgery. On a single occasion, the healthy volunteers will undergo the same detailed metabolic assessment performed in patients as described above. We will not examine the bacteria living in the gut of the healthy volunteers, nor will we collect gut tissue from these individuals.

CONDITIONS

Official Title

The Metabolic and Genetic Drivers of Body Composition Changes Following Weight Loss Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy volunteers aged 30 to 50 years
  • Healthy volunteers with BMI between 20 and 25 kg/m2
  • Healthy volunteers of any race or ethnicity
  • Healthy volunteers who can speak and read English
  • Healthy volunteers who provide informed consent and can follow trial procedures
  • Bariatric surgery patients aged 18 to 65 years
  • Bariatric surgery patients with BMI between 35 and 50 kg/m2
  • Bariatric surgery patients scheduled for surgery at UTMB
  • Bariatric surgery patients of any race or ethnicity
  • Bariatric surgery patients who can speak and read English
  • Bariatric surgery patients who provide informed consent and can follow trial procedures
  • Patients undergoing enhanced metabolic assessment must be aged 30 to 50 years and have gastric bypass surgery
Not Eligible

You will not qualify if you...

  • Healthy volunteers with heart, vascular, or lung disease
  • Healthy volunteers with uncontrolled blood pressure (systolic >170, diastolic >95 mmHg)
  • Healthy volunteers with impaired kidney function (creatinine >1.5 mg/dl)
  • Healthy volunteers with anemia (hematocrit <33% or blood donation in past 12 weeks)
  • Healthy volunteers with diabetes or untreated endocrine/metabolic disorders
  • Healthy volunteers with cancer history within 5 years
  • Healthy volunteers who used systemic or anabolic steroids, growth hormone, or immunosuppressants in past 6 months
  • Healthy volunteers on weight-loss or weight-gain diets causing 10%+ weight change in past 6 months
  • Healthy volunteers with BMI outside 19.5 to 25.5 kg/m2 or recent disordered eating
  • Healthy volunteers with acute or chronic infections
  • Healthy volunteers who are pregnant or breastfeeding
  • Healthy volunteers who used protein-based sports supplements in past month
  • Healthy volunteers with any condition increasing risk per investigator
  • Healthy volunteers allergic to any study agents including Phenylketonuria
  • Healthy volunteers unable to lie still supine for 10 minutes
  • Healthy volunteers with psychiatric conditions or history of non-compliance
  • Healthy volunteers in other research studies or using investigational agents within 30 days
  • Bariatric patients who fail medical criteria for surgery
  • Bariatric patients with anemia, cancer history within 5 years, or recent steroid/immunosuppressant use
  • Bariatric patients with BMI outside 35 to 50 kg/m2
  • Bariatric patients with acute or chronic infections
  • Bariatric patients who are pregnant or breastfeeding
  • Bariatric patients with any condition increasing risk per investigator
  • Bariatric patients with history of non-compliance
  • Bariatric patients in other research studies or using investigational agents within 30 days
  • Patients in enhanced assessment allergic to study agents including Phenylketonuria
  • Patients in enhanced assessment unable to lie still supine for 10 minutes
  • Patients in enhanced assessment with prior bariatric surgery or other procedures than gastric bypass

AI-Screening

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Trial Site Locations

Total: 1 location

1

The University of Texas Medical Branch

Galveston, Texas, United States, 77555

Actively Recruiting

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Research Team

A

Andrew J Murton, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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