Omics Profiling of Weight Loss With Bariatric Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/2/2017 |
| Start Date: | October 2015 |
| End Date: | October 2019 |
| Contact: | Marielle Engelen |
| Email: | mpkj.engelen@ctral.org |
| Phone: | 9792202282 |
Omics Profiling of the Response to Food and Variability of Weight Loss With Bariatric Surgery
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.
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.
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.
'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.
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
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