Bariatric Surgery Patients
Conditions
Keywords
Body composition, Sarcopenia, Weight loss surgery, Muscle function, Protein metabolism
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.
Interventions
None listed
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Dietary Protein Intake | 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. | 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 | 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. | 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 | A single occasion from tissue collected during the routine pre-operative upper endoscopy. (baseline) | 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 | 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. | 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. |
| Energy Intake | 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. | Energy intake assessed via the completion of a 3-day food diary. Will be performed on a single occasion in healthy volunteers and up to three times in bariatric patients undergoing metabolic assessment. |
Countries
United States
Contacts
CONTACTEmily J Lantz, PhD
PRINCIPAL_INVESTIGATOREmily J Lantz, PhD
The University of Texas Medical Branch
Outcome results
None listed