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

NCT ID: NCT04429386

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-15
• Study Completion Date: 2021-04-15

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.

Conditions

Obesity; Bariatric Surgery Candidate

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Bariatric surgery

Laparoscopic bariatric surgery including gastric bypass and sleeve gastrectomy

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRB#13-001552

Identifier Type: -

Identifier Source: org_study_id