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.
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
OBSERVATIONAL
Enrollment
22
Laparoscopic bariatric surgery including gastric bypass and sleeve gastrectomy
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).
Time frame: Measured at 6-months after bariatric surgery
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.
Time frame: Measured at 12-months after bariatric surgery
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).
Time frame: Measured at baseline and at 6-months after the bariatric surgery
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).
Time frame: Measured at baseline and at 12-months after the bariatric surgery
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).
Time frame: Measured at baseline and 6-months after the bariatric surgery
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).
Time frame: Measured at baseline and 12-months after the bariatric surgery
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
Time frame: Measured at baseline and at 6-months after the bariatric surgery
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
Time frame: Measured at baseline and at 12-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 6-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 12-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 6-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 12-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 6-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 12-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 6-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 12-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 6-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 12-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 6-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 12-months after the bariatric surgery
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
Time frame: 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
Functional brain images will be obtained using established acquisition protocols for resting state and evoked brain responses
Time frame: Measured at baseline and at 12-months after the bariatric surgery
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
Time frame: Measured at baseline and at 6-months after the bariatric surgery
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
Time frame: Measured at baseline and at 12-months after the bariatric surgery
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.
Time frame: Measured at baseline and at 6-months after the bariatric surgery
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.
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Time frame: Measured at baseline and at 12-months after the bariatric surgery