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ObesityNCT04429386

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

An observational study of Obesity and Bariatric Surgery Candidate, run by University of California, Los Angeles.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Obesity, Bariatric Surgery Candidate
What is being tested?
Bariatric surgery
Type of treatment
Surgery or procedure
How many people
22 participants
Where
No sites listed yet
Study dates
15 Feb 2014to 15 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

About this study

Official title: 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.

Read the 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.

Being tested
Bariatric surgery
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bariatric surgeryProcedure or surgery

    Laparoscopic bariatric surgery including gastric bypass and sleeve gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of excess weight loss at 6 months

    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: Measured at 6-months after bariatric surgery

  2. Percentage of excess weight loss at 12 months

    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: Measured at 12-months after bariatric surgery

  3. Change in Yale Food Addiction Scale score at 6 months

    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: Measured at baseline and at 6-months after the bariatric surgery

  4. Change in Yale Food Addiction Scale score at 12 months

    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: Measured at baseline and at 12-months after the bariatric surgery

  5. Change in Three-Factor Eating Questionnaire score at 6-months

    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: Measured at baseline and 6-months after the bariatric surgery

  6. Change in Three-Factor Eating Questionnaire score at 12-months

    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: Measured at baseline and 12-months after the bariatric surgery

  7. Change in diet (3-day food intake record) at 6-months.

    3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients

    Measured: Measured at baseline and at 6-months after the bariatric surgery

  8. Change in diet (3-day food intake record) at 12-months.

    3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients

    Measured: Measured at baseline and at 12-months after the bariatric surgery

  9. Changes in blood levels of Ghrelin at 6-months

    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: Measured at baseline and at 6-months after the bariatric surgery

  10. Changes in blood levels of Ghrelin at 12-months

    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: Measured at baseline and at 12-months after the bariatric surgery

  11. Changes in blood levels of glucagon-like peptide (GLP)-1 at 6-months

    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: Measured at baseline and at 6-months after the bariatric surgery

  12. Changes in blood levels of glucagon-like peptide (GLP)-1 at 12-months

    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: Measured at baseline and at 12-months after the bariatric surgery

  13. Changes in blood levels of Peptide YY at 6-months

    Serum levels of peptideYY(PYY). Units of Peptide YY in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.

    Measured: Measured at baseline and at 6-months after the bariatric surgery

  14. Changes in blood levels of Peptide YY at 12-months

    Serum levels of peptideYY(PYY). Units of Peptide YY in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these hormones.

    Measured: Measured at baseline and at 12-months after the bariatric surgery

  15. Changes in blood levels of insulin at 6-months

    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: Measured at baseline and at 6-months after the bariatric surgery

  16. Changes in blood levels of insulin at 12-months

    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: Measured at baseline and at 12-months after the bariatric surgery

  17. Changes in blood levels of leptin at 6-months

    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: Measured at baseline and at 6-months after the bariatric surgery

  18. Changes in blood levels of leptin at 12-months

    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: Measured at baseline and at 12-months after the bariatric surgery

  19. Changes in gut microbiome at 6 months

    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: Measured at baseline and at 6-months after the bariatric surgery

  20. Changes in gut microbiome at 12 months

    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: Measured at baseline and at 12-months after the bariatric surgery

Secondary outcomes (6)

  1. Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 6 months

    Functional brain images will be obtained using established acquisition protocols for resting state and evoked brain responses

    Measured: Measured at baseline and at 6-months after the bariatric surgery

  2. Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 12 months

    Functional brain images will be obtained using established acquisition protocols for resting state and evoked brain responses

    Measured: Measured at baseline and at 12-months after the bariatric surgery

  3. Changes in Inflammatory markers at 6 months

    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: Measured at baseline and at 6-months after the bariatric surgery

  4. Changes in Inflammatory markers at 12 months

    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: Measured at baseline and at 12-months after the bariatric surgery

  5. Changes in metabolite concentrations at 6 months.

    Differences in blood metabolite concentrations measured by mass spectrometry, comparing metabolite concentrations from obese patients at baseline and after bariatric surgery.

    Measured: Measured at baseline and at 6-months after the bariatric surgery

  6. Changes in metabolite concentrations at 12 months.

    Differences in blood metabolite concentrations measured by mass spectrometry, comparing metabolite concentrations from obese patients at baseline and after bariatric surgery.

    Measured: Measured at baseline and at 12-months after the bariatric surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2020
  2. Study start15 Feb 2014
  3. Primary completion15 Apr 2021
  4. Study completion15 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04429386
Sponsor's protocol ID
IRB#13-001552
Status last verified
Aug 2021
First submitted
6 May 2020
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Bariatric Surgery Candidate, run by University of California, Los Angeles.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of excess weight loss at 6 months (time frame: Measured at 6-months after bariatric surgery). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04429386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.

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