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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorThe University of Texas Medical Branch, Galveston

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Bariatric Surgery Patients

Trial outcomes

Primary outcomes

1

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.

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 outcomes

1

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.

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.
2

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.

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.
3

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.

Time frame
A single occasion from tissue collected during the routine pre-operative upper endoscopy. (baseline)
4

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.

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.

Other outcomes

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