Omics Profiling of Weight Loss With Bariatric Surgery

NCT02757638 | Completed

• 1 other identifier: 2014-0651
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Surgery

Outcome Measures

Primary Outcomes (1)

• Net whole-body protein synthesis

  Change in whole-body protein synthesis rate after intake of meal

  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

Secondary Outcomes (17)

• 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)

Study Arms (2)

Healthy matched controls

EXPERIMENTAL

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.

Other: Stable isotope infusion

Obese subjects

EXPERIMENTAL

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.

Other: Stable isotope infusion

Interventions

Stable isotope infusion OTHER

such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline

Healthy matched controls; Obese subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77843, United States

Location

Related Publications (1)

• Wierzchowska-McNew RA, Engelen MPKJ, Thaden JJ, Ten Have GAM, Deutz NEP. Obesity- and sex-related metabolism of arginine and nitric oxide in adults. Am J Clin Nutr. 2022 Dec 19;116(6):1610-1620. doi: 10.1093/ajcn/nqac277.

  PMID: 36166849 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marielle Engelen, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: May 2, 2016
• Study Start: February 25, 2016
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)