Bariatric Surgery Candidate, Obesity
Conditions
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.
Interventions
PROCEDUREBariatric surgery
Laparoscopic bariatric surgery including gastric bypass and sleeve gastrectomy
Sponsors
University of California, Los Angeles
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in gut microbiome at 12 months | 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. |
| Changes in blood levels of Peptide YY at 12-months | 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. |
| Changes in blood levels of insulin at 6-months | 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. |
| Changes in blood levels of insulin at 12-months | 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. |
| Changes in blood levels of leptin at 6-months | 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. |
| Changes in blood levels of leptin at 12-months | 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. |
| Changes in gut microbiome at 6 months | 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. |
| Percentage of excess weight loss at 6 months | 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). |
| Percentage of excess weight loss at 12 months | 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. |
| Change in Yale Food Addiction Scale score at 6 months | 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). |
| Change in Yale Food Addiction Scale score at 12 months | 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). |
| Change in Three-Factor Eating Questionnaire score at 6-months | 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). |
| Change in Three-Factor Eating Questionnaire score at 12-months | 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). |
| Change in diet (3-day food intake record) at 6-months. | 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 |
| Change in diet (3-day food intake record) at 12-months. | 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 |
| Changes in blood levels of Ghrelin at 6-months | 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. |
| Changes in blood levels of Ghrelin at 12-months | 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. |
| Changes in blood levels of glucagon-like peptide (GLP)-1 at 6-months | 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. |
| Changes in blood levels of glucagon-like peptide (GLP)-1 at 12-months | 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. |
| Changes in blood levels of Peptide YY at 6-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 12 months | 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 |
| Changes in Inflammatory markers at 6 months | 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 |
| Changes in Inflammatory markers at 12 months | 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 |
| Changes in metabolite concentrations at 6 months. | 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. |
| Changes in metabolite concentrations at 12 months. | 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. |
| Changes in Brain function as measured by functional magnetic resonance imaging ( fMRI) at 6 months | 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 |
Outcome results
None listed