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Omics Profiling of Weight Loss With Bariatric Surgery (Bariatric)

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ClinicalTrials.gov Identifier: NCT02757638
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University

Tracking Information
First Submitted Date  ICMJE February 1, 2016
First Posted Date  ICMJE May 2, 2016
Last Update Posted Date October 31, 2017
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02757638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2016)
  • Group differences in state of mood as measured by the Hospital Anxiety and Depression Scale (HADS), [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    a fourteen item self-assessment scale. Seven of the items related to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression.
  • Executive Function-Adolescent/Adult Sensory Profile (ASP): [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    a standardized self-questionnaire that generates an individualized profile of sensory processing across four quadrants: low registration, sensation seeking, sensory sensitivity, and sensation avoiding.
  • Group differences in quality of life as measured by Short Form (36) Health Survey (SF36) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT).
  • Group differences in activity as measured by Physical Activity Scale for the Elderly (PASE) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    questionnaire is intended for use in an elderly population and focuses on 3 types of activities: leisure time activities, household activities and work-related activities.
  • Group differences in attention and executive functions as measured by Stroop Color-Word Test (SCWT), [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    a word page with words printed in black ink, a color page with blocks printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The total time in seconds was reported for each trial.
  • Group differences in state of mood as measured by the Profile of Mood State (POMS) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    A psychological distress scale to measure mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. Healthy populations take 3 to 7 minutes to complete, and others may take up a bit longer.
  • Group differences in learning and memory as measured by Controlled Oral Word Association Test (COWAT), [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    Controlled Oral Word Association Test (COWAT): The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total and mean words recorded across the three trials) was reported.
  • Group differences in learning and memory as measured by Auditory Verbal Learning Test (AVLT) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    Auditory Verbal Learning Test (AVLT): a verbal episodic memory test that evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, retention and recognition of information.
  • Group differences in attention and executive functions as measured by PASAT [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.
  • Group differences in attention and executive functions as measured by Trail Making Test (TMT), [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    In Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and mental flexibility. The total time in seconds was reported for each measure.
  • Group differences in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA) [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning.
  • Group differences in attention and executive functions as measured by Brief-A [ Time Frame: Postabsorptive state during 3 hours and change after feeding on study day 1 and the change from day 2 and day 3 (obese only) ]
    a standardized self-report that captures views of an adult's executive functions or self-regulation in his or her everyday environment.
  • Skeletal muscle strength [ Time Frame: on study day 1 and the change from day 2 and day 3 (obese only) ]
    handgrip and kin-com 1-leg test
  • diet recall [ Time Frame: on study day 1 and the change from day 2 and day 3 (obese only) ]
    The subject is asked to recall in detail all the food and drink consumed during the 24 hours prior to the test day.
  • Respiratory muscle strength [ Time Frame: on study day 1 and the change from day 2 and day 3 (obese only) ]
    Maximum inhalation and exhalation pressure
  • Body Composition [ Time Frame: on study day 1 and the change from day 2 and day 3 (obese only) ]
    Body composition as measured by Dual-Energy X-ray Absorptiometry on study day 1 and the change from day 2 and day 3 (obese only)
  • Gut function [ Time Frame: In postabsorptive and prandial state every 20 minutes up to 6 hours before each sip feeding on study day ]
    Digestion of the stable tracers of amino acid
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Omics Profiling of Weight Loss With Bariatric Surgery
Official Title  ICMJE Omics Profiling of the Response to Food and Variability of Weight Loss With Bariatric Surgery
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.

Specific Aim 3: To test whether there are "omics" characteristics post-surgery that track with variability in weight loss at 3 months.

The benefit of these experiments will be the knowledge gained from understanding the variation in % weight loss to the medically required VLC diet prior to bariatric surgery, and to bariatric surgery, in relation to baseline genomic markers, gene expression profile, proteomic and metabolomic signatures as well as baseline metabolic and substrates fluxomics response to a defined meal in obese and healthy adults.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Obesity
  • Surgery
Intervention  ICMJE Other: Stable isotope infusion
such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
Study Arms
  • Experimental: 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: Other: Stable isotope infusion
  • Experimental: 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: Other: Stable isotope infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date October 2019
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE
Contact: Marielle Engelen 9792202282 mpkj.engelen@ctral.org
Contact: Agata McNew 979-583-5800 a.wierzchowska@ctral.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02757638
Other Study ID Numbers  ICMJE 2014-0651
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marielle PKJ Engelen, PhD, Texas A&M University
Study Sponsor  ICMJE Texas A&M University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marielle Engelen, PhD Texas A&M University
PRS Account Texas A&M University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP