Brain Gut Axis Changes After Bariatric Surgery and Their Relationship to Weight Loss

August 11, 2021 updated by: University of California, Los Angeles

Brain Responses Associated With Ingestive Behavior in Obese Women: the Effects of Bariatric Surgery, and Their Association With Behavioral, Satiety Signal Responses and Weight Loss

Assessing the changes in the brain-gut axis after weight loss surgery and their relationship with weight loss and changes in eating behaviors.

Obese women undergoing weight loss surgery will be recruited to participate in the study. These individuals will undergo a screening visit and 4 study visits. The study visits will occur before, and at 1-, 6- and 12 months after the weight loss surgery. Each study visit will include evaluation of brain function (fMRI), anthropometrics, blood and stool samples and eating behaviors questionnaires.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Assessing the changes in the brain-gut axis after weight loss surgery and their relationship with weight loss and changes in eating behaviors.

Obese women undergoing weight loss surgery will be recruited to participate in the study. These subjects will undergo a screening visit and 4 study visits. The study visits will occur before, and at 1-, 6- and 12 months after the weight loss surgery. Each study visit will include evaluation of brain function (fMRI), anthropometrics, blood samples (gut hormones, cytokines, metabolomics ) and stool samples (16S RNA and Metabolomics) and eating behaviors questionnaires (YFAS, TFEQ, food cravings/preferences scales, 3-day food food intake records)

Primary outcomes: weight loss after surgery and changes in eating behaviors scales (YFAS, TFEQ) , metabolomics, appetite related hormones and gut microbiome (16S RNA) Secondary outcomes: changes in brain function (fMRI/MRS), diet (3-day food intake records) and inflammatory markers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

We will include obese women undergoing bariatric surgery as part of standard medical care.

Description

Inclusion Criteria:

  • Women, age 18-55 years
  • Eligible and approved for undergoing laparoscopic gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) following the Guidelines for Clinical application of Laparoscopic Bariatric Surgery by of American Gastrointestinal and Endoscopic Surgeons (SAGES)
  • Right-handed

Exclusion Criteria:

  • Previous major gastrointestinal surgery including weight loss surgery (partial or complete resection of stomach and/or small bowel, Whipple procedure, etc)
  • Use of medications known to affect hunger, satiety, or intestinal motility.
  • Unwillingness or inability to give informed consent
  • Any contraindication to undergo MRI
  • Current or past alcohol or drug abuse problem or smoking
  • Pregnancy, lactating or post partum less than 12 months
  • Body weight at enrollment greater than 350 lbs.
  • Current use of insulin and or insulin dependent diabetes
  • Renal insufficiency, retinopathy, or neuropathy.
  • Post menopausal (defined as no menses for 12 consecutive months)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of excess weight loss at 6 months
Time Frame: Measured at 6-months after bariatric surgery
Measure of weight loss, it is calculated using the following formula: preoperative weight - weight at the follow-up visit)/(preoperative weight - Ideal body weight *100. Greater values mean greater weight loss (better).
Measured at 6-months after bariatric surgery
Percentage of excess weight loss at 12 months
Time Frame: Measured at 12-months after bariatric surgery
Measure of weight loss, it is calculated using the following formula: preoperative weight - weight at the follow-up visit)/(preoperative weight - Ideal body weight *100. Greater values mean greater weight loss (better). Greater values are better.
Measured at 12-months after bariatric surgery
Change in Yale Food Addiction Scale score at 6 months
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
Yale Food Addiction Scale that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).
Measured at baseline and at 6-months after the bariatric surgery
Change in Yale Food Addiction Scale score at 12 months
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
Yale Food Addiction Scale that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse).
Measured at baseline and at 12-months after the bariatric surgery
Change in Three-Factor Eating Questionnaire score at 6-months
Time Frame: Measured at baseline and 6-months after the bariatric surgery
Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).
Measured at baseline and 6-months after the bariatric surgery
Change in Three-Factor Eating Questionnaire score at 12-months
Time Frame: Measured at baseline and 12-months after the bariatric surgery
Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse).
Measured at baseline and 12-months after the bariatric surgery
Change in diet (3-day food intake record) at 6-months.
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients
Measured at baseline and at 6-months after the bariatric surgery
Change in diet (3-day food intake record) at 12-months.
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients
Measured at baseline and at 12-months after the bariatric surgery
Changes in blood levels of Ghrelin at 6-months
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
Serum levels of Ghrelin. Units of gut hormones include Ghrelin in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
Measured at baseline and at 6-months after the bariatric surgery
Changes in blood levels of Ghrelin at 12-months
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
Serum levels of Ghrelin. Units of gut hormones include Ghrelin in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
Measured at baseline and at 12-months after the bariatric surgery
Changes in blood levels of glucagon-like peptide (GLP)-1 at 6-months
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
Serum levels of glucagon-like peptide (GLP)-1. Units of gut hormones include GLP-1 in pmol/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
Measured at baseline and at 6-months after the bariatric surgery
Changes in blood levels of glucagon-like peptide (GLP)-1 at 12-months
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
Serum levels of glucagon-like peptide (GLP)-1. Units of gut hormones include GLP-1 in pmol/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
Measured at baseline and at 12-months after the bariatric surgery
Changes in blood levels of Peptide YY at 6-months
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
Serum levels of peptideYY(PYY). Units of Peptide YY in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
Measured at baseline and at 6-months after the bariatric surgery
Changes in blood levels of Peptide YY at 12-months
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
Serum levels of peptideYY(PYY). Units of Peptide YY in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
Measured at baseline and at 12-months after the bariatric surgery
Changes in blood levels of insulin at 6-months
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
Serum levels of insulin. Units of gut hormones include insulin in ulu/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
Measured at baseline and at 6-months after the bariatric surgery
Changes in blood levels of insulin at 12-months
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
Serum levels of insulin. Units of gut hormones include insulin in ulu/L. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
Measured at baseline and at 12-months after the bariatric surgery
Changes in blood levels of leptin at 6-months
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
Serum levels of leptin. Units of gut hormones include Leptin in ng/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
Measured at baseline and at 6-months after the bariatric surgery
Changes in blood levels of leptin at 12-months
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
Serum levels of leptin. Units of gut hormones include Leptin in ng/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.
Measured at baseline and at 12-months after the bariatric surgery
Changes in gut microbiome at 6 months
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
High-Throughput Microbiome Sequencing for sequencing of the 16S ribosomal RNA. Output sequences are classified as domain, phylum, family and genus to species, depending on the depth of reliable classifier assignments ribosomal RNA (rRNA) gene as the genetic marker to study bacterial phylogeny and taxonomy.
Measured at baseline and at 6-months after the bariatric surgery
Changes in gut microbiome at 12 months
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
High-Throughput Microbiome Sequencing for sequencing of the 16S ribosomal RNA. Output sequences are classified as domain, phylum, family and genus to species, depending on the depth of reliable classifier assignments ribosomal RNA (rRNA) gene as the genetic marker to study bacterial phylogeny and taxonomy.
Measured at baseline and at 12-months after the bariatric surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 6 months
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
Functional brain images will be obtained using established acquisition protocols for resting state and evoked brain responses
Measured at baseline and at 6-months after the bariatric surgery
Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 12 months
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
Functional brain images will be obtained using established acquisition protocols for resting state and evoked brain responses
Measured at baseline and at 12-months after the bariatric surgery
Changes in Inflammatory markers at 6 months
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
Serum levels of adipokines and inflammatory cytokines. Units include: Adiponectin in pg/ml, Interleukin 1β in pg/ml , Interleukin 6 in pg/ml, Lipopolysaccharide in pg/ml, tumor-necrosis-factor TNF-α in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines
Measured at baseline and at 6-months after the bariatric surgery
Changes in Inflammatory markers at 12 months
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
Serum levels of adipokines and inflammatory cytokines. Units include: Adiponectin in pg/ml, Interleukin 1β in pg/ml , Interleukin 6 in pg/ml, Lipopolysaccharide in pg/ml, tumor-necrosis-factor TNF-α in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines
Measured at baseline and at 12-months after the bariatric surgery
Changes in metabolite concentrations at 6 months.
Time Frame: Measured at baseline and at 6-months after the bariatric surgery
Differences in blood metabolite concentrations measured by mass spectrometry, comparing metabolite concentrations from obese patients at baseline and after bariatric surgery.
Measured at baseline and at 6-months after the bariatric surgery
Changes in metabolite concentrations at 12 months.
Time Frame: Measured at baseline and at 12-months after the bariatric surgery
Differences in blood metabolite concentrations measured by mass spectrometry, comparing metabolite concentrations from obese patients at baseline and after bariatric surgery.
Measured at baseline and at 12-months after the bariatric surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB#13-001552

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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