Emotional Regulation, Cognition, Impulsivity and Reward System in Obesity: A Prospective Study of Bariatric Surgery

NCT03528044 | Completed

• 2 other identifiers: KocU Bari2017.081.IRB1.011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This research investigates obesity and associated psychiatric symptoms and disorders in a wide range of perspectives, to demonstrate the effects of obesity on the brain. The 1st aim is to assess the psychiatric symptom profiles in the group of obese patients applying for bariatric surgery and to determine the associated environmental stress factors. While, it is known that eating disorders, mood disorders and psychiatric drugs can cause obesity, obesity can also cause many psychiatric complications such as depression and cognitive disorders. There are no multi-centered studies that are conducted in this respect, and the guidelines on pre-evaluation and follow-up of patients are also lacking. The 2nd aim is to evaluate and monitor cognitive characteristics before and after bariatric surgery in obese patients. Obese people are at increased risk of dementia and are more likely to have cognitive deficits, especially executive function problems, that can affect everyday life. For this reason, obese individuals should be examined and monitored in more detail in terms of their cognitive characteristics and the change of cognitive functions during the weight loss process. The 3rd aim is to examine the relationship between obesity, bariatric surgery and reward processing system. Studies have been limited in determining whether addiction in these people is due to a search of a continuous substance as a cognitive feature or whether it is difficult to terminate it as an impulsive behavior when encountered with a pleasurable substance, even though there is no reward seeking or reward dependence. The 4th aim is the determination of the neuroanatomical and molecular components of cognitive changes observed after bariatric surgery. During the dynamic process following bariatric surgery, a variety of metabolites, chemokines, and microbiota changes may also affect the brain health and cognition. The 5th aim is to determine factors of eating, emotional regulation, reward system, addiction and impulsivity, and other psychopathologies that cause suboptimal weight loss or weight gain after bariatric surgery. Understanding the psychological and neurobiological factors involved in these processes can improve surgical interventions and significantly increase the quality of life for patients.

Conditions

Obesity; Cognitive Disorder

Keywords

Bariatric surgery; Reward; Cognition; Working memory; Grey matter; GLP-1; Inflammation; Stress; Follow-up; Psychiatric

Outcome Measures

Primary Outcomes (2)

• Changes in working memory following bariatric surgery

  Letter-and-Back Task in the PENN-CNP neuropsychological battery will be used to assess working memory. Letter-and-Back asks participants to focus on letters on the screen and press the spacebar according to certain rules. The task consists of three parts: 0-back, 1-back, 2-back. During 0-back, participants press the spacebar when they see letter "X" on the screen. During 1-back, participants press the spacebar when they see the same letter twice. During 2-back, participants press the spacebar when the letter on the screen is the same as the letter before the previous letter.

  Pre-surgery, 3rd and 12th months after bariatric surgery

• Grey-matter changes in the entire brain, focused assessments on brain areas known to be associated with cognitive functions

  Structural and functional changes in the brain will be evaluated by magnetic resonance imaging (MRI). Thin-section T1-weighted images for evaluation of gray matter changes, resting functional magnetic resonance images for evaluation of functional changes will be obtained. For resting fMRI, patients will be asked to rest eyes closed for 6 minutes without thinking anything. Imaging will take approximately 30 minutes.

  MRI examination will be repeated both for the obese patient group and concurrently healthy controls before surgery (0 months) and after surgery at 3 and 12 months.

Secondary Outcomes (6)

• Changes in impulsivity following bariatric surgery

  Pre-surgery, 3rd and 12th months after bariatric surgery

• Success of surgery

  3rd and 12th months after bariatric surgery

• Changes in inflammator factors following bariatric surgery

  Pre-surgery, 3rd and 12th months after bariatric surgery

• Changes in GLP1 will be analyzed following bariatric surgery

  Pre-surgery, 3rd and 12th months after bariatric surgery

• Changes in social cognition following bariatric surgery

  Pre-surgery, 3rd and 12th months after bariatric surgery

Study Arms (2)

Patients undergoing bariatric surgery

EXPERIMENTAL

In this study, patients will undergo sleeve gastrectomy to reduce the size of the stomach to induce weight loss.

Procedure: Bariatric surgery

Control group

NO INTERVENTION

Healthy controls with normal BMI.

Interventions

Bariatric surgery PROCEDURE

In this study, patients will undergo sleeve gastrectomy to reduce the size of the stomach to induce weight loss.

Patients undergoing bariatric surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 18-65
• To be able to give informed consent
• Be a candidate for bariatric surgery.

You may not qualify if:

• Dementia
• Individuals with severe mental retardation and marked cognitive impairments
• Psychotic disorders
• Psychoactive substance addiction diagnosis
• For healthy volunteers:
• Be between the ages of 18-65
• To be able to give informed consent
• To be in normal range for BMI
• To be observed as in the normal mental status examination
• Dementia
• Individuals with severe mental retardation and marked cognitive impairments
• Psychotic disorders
• Psychoactive substance addiction diagnosis

Sponsors & Collaborators

• Koç University: lead
• Fatih Sultan Mehmet Training and Research Hospital: collaborator
• Marmara University: collaborator

Study Sites (3)

Fatih Sultan Mehmed Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Koc University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Obesity; Cognitive Dysfunction; Inflammation

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Hale Yapici Eser, MD, PHD

  Koc University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study, patients undergoing bariatric surgery will be assessed at baseline and after bariatric surgery. We intend to analyze the changes in this repeated and dependent measurements. The other group will be undisturbed during the follow up except for clinical assessments and MRI imaging.

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: May 17, 2018
• Study Start: June 6, 2017
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)