Recruiting

Bariatric Surgery

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07178704

Conditions

Bariatric Surgery Patients

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

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. In patients who undergo a routine endoscopy in advance of weight loss surgery a small sample of gut tissue will be collected to identify the expression (activity) of genes in their DNA.

Conditions

Bariatric Surgery Patients

Study ID

NCT07178704

Start date

Nov 4, 2025

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria (Bariatric Surgery Patients):

  • Age: 18 to 65 years at time of consent
  • BMI: 35-65 kg.m-2
  • Scheduled to undergo bariatric surgery at UTMB
  • All races and ethnic backgrounds
  • Ability to speak and read English
  • Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.

Exclusion Criteria (Bariatric Surgery Patients):

  • Fails the medical criteria for bariatric surgery.
  • Anemia (hematocrit < 33 % or donated blood in the past 12 weeks.)
  • Recent (5 years or less) history of cancer
  • Systemic steroids or immunosuppressant use for 8 or more consecutive days in the past 6 months, or any use of anabolic steroids or growth hormones in the same period.
  • Body mass index < 35 or > 65 kg.m-2.
  • Acute infectious disease or chronic infection.
  • Pregnancy or breast-feeding.
  • Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
  • History of prior non-compliance that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigator's instructions.
  • Concurrent participation in another research study.
  • Use of an investigational agent in the 30 days prior to signing informed consent.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Bariatric Surgery Patients

Patients due to undergo either sleeve gastrectomy or gastric bypass surgery.

Primary outcome measure

  • Body composition [ Time Frame: Measured at baseline in both healthy volunteers & bariatric surgery patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery. ]

Central Contacts and Locations

Central contacts

Emily J Lantz, PhD

409-772-0643ejlantz@utmb.edu

Locations

The University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Emily J Lantz, PhD

409-772-0643ejlantz@utmb.edu

Principal Investigator:

Emily J Lantz, PhD

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Body composition
  • Sarcopenia
  • Weight loss surgery
  • Muscle function
  • Protein metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-07-10.