Obesity Clinical Trial - Omics Profiling of Weight Loss With Bariatric

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02757638
Study type	Interventional
Source	Texas A&M University
Contact
Status	Active, not recruiting
Phase	N/A
Start date	October 2015
Completion date	October 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Omics Profiling of Weight Loss With Bariatric Surgery — Bariatric

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms