The Metabolic and Genetic Drivers of Body Composition Changes Following Weight Loss Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Patients. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PILOT STUDY: The Metabolic and Genetic Drivers of Body Composition Changes Following Weight Loss Surgery
Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (5)
- Dietary Protein Intake [Time frame: Measured at baseline in both healthy volunteers & patients undergoing metabolic assessment. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.]
- Body weight [Time frame: Measured at baseline in both healthy volunteers & bariatric surgery patients. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.]
- Association between foregut gene expression and degree of weight reduction [Time frame: A single occasion from tissue collected during the routine pre-operative upper endoscopy. (baseline)]
- Handgrip Strength [Time frame: Measured at baseline in both healthy volunteers & bariatric surgery patients. The latter will undergo repeat assessment on two further occasions across a 1 year period post surgery.]
- Energy Intake [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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The University of Texas Medical Branch — Galveston
Identifiers
NCT: NCT07178704 · 24-0361