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

NCT04429386 | Completed

• 1 other identifier: IRB#13-001552
• Study Type: observational
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (20)

• 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 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.

  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).

  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).

  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).

  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).

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (6)

• 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

• 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

• Changes in Inflammatory markers at 6 months

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

• Changes in Inflammatory markers at 12 months

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

• Changes in metabolite concentrations at 6 months.

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

Interventions

Bariatric surgery PROCEDURE

Laparoscopic bariatric surgery including gastric bypass and sleeve gastrectomy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples for 16S RNA analysis

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: June 12, 2020
• Study Start: February 15, 2014
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08