Omics Profiling of the Response to Food and Variability of Weight Loss With Bariatric Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Texas A&M University
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Net whole-body protein synthesis
Study Overview
Brief Summary
Understanding how foods and nutrients are digested, absorbed and metabolized when weight is stable and during weight loss induced by bariatric surgery procedure using the technologies of genomics, transcriptomics, proteomics, metabolomics and fluxomics ("omics") will enable generation of new hypotheses that could explain the inter-individual differences in weight loss and could lead to optimization and individualization of therapies designed to lose weight.
Detailed Description
The overarching hypothesis is that there are baseline, pre- and post-surgery combinations of 'omics' signatures in response to food and nutrients that explain the weight loss response of obese subjects to the pre-operative very low calorie (VLC) diet and to bariatric surgery.
In order to address the general hypothesis the following specific aims will be addressed:
Specific Aim 1: To test the hypothesis that there is a combination of 'omics' parameters in response to a defined meal that discriminate between morbidly obese subjects and normal weight subjects.
Specific Aim 2: To test the hypothesis that variation in % weight loss to the VLC diet prior to bariatric surgery is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.
Specific Aim 2: To test the hypothesis that variation in % weight loss 3 months after bariatric surgery is related to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •obese subjects:
- •Diagnosed with morbid obesity (defined as BMI > 40 kg/m2 or BMI > 35 kg/m2 with at least one serious comorbidity (1991 NIH compendium guidelines))
- •Scheduled for bariatric surgery
- •Age 18 years and older
- •Ability to lie in supine or elevated position for 9 hours
- •Willingness and ability to comply with the protocol
- •Inclusion criteria healthy subjects:
- •Healthy male or female according to the investigator's or appointed staff's judgment
- •Ability to walk, sit down and stand up independently
- •Age 18 years or older
- •Ability to lie in supine or elevated position for 9 hours
- •Willingness and ability to comply with the protocol
Exclusion Criteria
- •Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only)
- •Presence of fever within the last 3 days
- •Untreated metabolic diseases including hepatic or renal disorder unrelated to the primary disease
- •Presence of acute illness or metabolically unstable chronic illness unrelated to the primary disease
- •(Possible) pregnancy
- •Any other condition according to the PI or nurse that would interfere with the study or safety of the patient
- •Failure to give informed consent
- •Use of protein or amino acid containing nutritional supplements within 3 days of first test day
Arms & Interventions
Healthy matched controls
screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical and psychological information about them that will help determine study eligibility or can be used for later coding.
study day: muscle mass and function tests, resting energy expenditure, stable isotope infusions with blood draws, and questionnaires regarding quality of life, mood and depression, diet.
Intervention: Stable isotope infusion (Other)
Obese subjects
screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Subjects may sign a medical release form to obtain medical and psychological information about them that will help determine study eligibility or can be used for later coding.
3 study days (one baseline, one pre-surgery, one post-surgery): muscle mass and function tests, resting energy expenditure, stable isotope infusions with blood draws, and questionnaires regarding quality of life, mood and depression, diet.
Intervention: Stable isotope infusion (Other)
Outcomes
Primary Outcomes
Net whole-body protein synthesis
Time Frame: 0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 225, 240, 260, 280, 300, 320, 340, 360 ± 5 min
Change in whole-body protein synthesis rate after intake of meal
Secondary Outcomes
- Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS),(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Executive Function-Adolescent/Adult Sensory Profile (ASP):(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Group differences in quality of life as measured by Short Form (36) Health Survey (SF36)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT),(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Group differences in state of mood as measured by the Profile of Mood State (POMS)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT),(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Group differences in attention and executive functions as measured by PASAT(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Group differences in attention and executive functions as measured by Trail Making Test (TMT),(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Group differences in attention and executive functions as measured by Brief-A(Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only))
- Skeletal muscle strength(on study day 1 and the change from day 2 and day 3 (obese only))
- diet recall(on study day 1 and the change from day 2 and day 3 (obese only))
- Respiratory muscle strength(on study day 1 and the change from day 2 and day 3 (obese only))
- Body Composition(on study day 1 and the change from day 2 and day 3 (obese only))
- Gut function(In postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on study day)
Investigators
Marielle PKJ Engelen, PhD
Associate Professor
Texas A&M University