About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients will be recruited from those electing to undergo bariatric surgery at the University of Texas Medical Branch.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Body composition
Body composition will be determined in patients by whole-body bioelectrical impedance. Regional body composition will be additionally assessed in healthy volunteers and bariatric surgery patients undergoing metabolic assessment via whole-body dual-energy x-ray absorptiometry (DXA) imaging. Procedures will be performed on a single occasion in healthy volunteers and up to three times in bariatric patients undergoing metabolic assessment.
Secondary outcomes
Dietary Protein Intake
Dietary protein intake will be determined by participants completing three-day food diaries. This will be performed on a single occasion in healthy volunteers and up to three occasions in bariatric patients undergoing metabolic assessment.
Body weight
Body weight will be determined using digital scales (in kg). Procedures will be performed on a single occasion in healthy volunteers and up to three times in bariatric patients.
Association between foregut gene expression and degree of weight reduction
Assessed only in patients. Gene expression of the foregut will be analyzed in tissue collected from patients during the routine pre-operative upper endoscopy. Subsequently, participants will be stratified into those achieving: \<10%, 10-20%, or \>20% weight loss 12 months post-surgery, and differentially expressed genes between the three groups determined.
Handgrip Strength
Assessed using a handgrip dynamometer (in kg). Will be performed on a single occasion in healthy volunteers and up to three times in bariatric patients.
Sponsors and contacts
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