Clinical trial NCT04429386: Brain Gut Axis Changes After Bariatric Surgery and Their Relationship to Weight Loss
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery Candidate
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will include obese women undergoing bariatric surgery as part of standard medical care.

Brief 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. 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of excess weight loss at 6 months
timeFrame: Measured at 6-months after bariatric surgery
measure: Percentage of excess weight loss at 12 months
timeFrame: Measured at 12-months after bariatric surgery
measure: Change in Yale Food Addiction Scale score at 6 months
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Change in Yale Food Addiction Scale score at 12 months
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
measure: Change in Three-Factor Eating Questionnaire score at 6-months
timeFrame: Measured at baseline and 6-months after the bariatric surgery
measure: Change in Three-Factor Eating Questionnaire score at 12-months
timeFrame: Measured at baseline and 12-months after the bariatric surgery
measure: Change in diet (3-day food intake record) at 6-months.
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Change in diet (3-day food intake record) at 12-months.
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
measure: Changes in blood levels of Ghrelin at 6-months
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Changes in blood levels of Ghrelin at 12-months
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
measure: Changes in blood levels of glucagon-like peptide (GLP)-1 at 6-months
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Changes in blood levels of glucagon-like peptide (GLP)-1 at 12-months
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
measure: Changes in blood levels of Peptide YY at 6-months
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Changes in blood levels of Peptide YY at 12-months
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
measure: Changes in blood levels of insulin at 6-months
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Changes in blood levels of insulin at 12-months
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
measure: Changes in blood levels of leptin at 6-months
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Changes in blood levels of leptin at 12-months
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
measure: Changes in gut microbiome at 6 months
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Changes in gut microbiome at 12 months
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
Secondary outcomes:
measure: Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 6 months
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 12 months
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
measure: Changes in Inflammatory markers at 6 months
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Changes in Inflammatory markers at 12 months
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
measure: Changes in metabolite concentrations at 6 months.
timeFrame: Measured at baseline and at 6-months after the bariatric surgery
measure: Changes in metabolite concentrations at 12 months.
timeFrame: Measured at baseline and at 12-months after the bariatric surgery
Other outcomes:
Locations:
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