Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528044
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : November 20, 2020
Sponsor:
Collaborators:
Fatih Sultan Mehmet Training and Research Hospital
Marmara University
Information provided by (Responsible Party):
Koç University

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.

Condition or disease Intervention/treatment Phase
Obesity Cognitive Disorder Procedure: Bariatric surgery Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation and Follow up of Emotional Regulation, Cognition, Impulsivity and Reward System in Obesity, and Determination of Its Biopsychosocial Risk Factors: A Prospective Study of Obese Patients Before and After Bariatric Surgery
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : June 6, 2021
Estimated Study Completion Date : June 6, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients undergoing bariatric surgery
In this study, patients will undergo sleeve gastrectomy to reduce the size of the stomach to induce weight loss.
Procedure: Bariatric surgery
In this study, patients will undergo sleeve gastrectomy to reduce the size of the stomach to induce weight loss.

No Intervention: Control group
Healthy controls with normal BMI.



Primary Outcome Measures :
  1. Changes in working memory following bariatric surgery [ Time Frame: Pre-surgery, 3rd and 12th months after 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.

  2. Grey-matter changes in the entire brain, focused assessments on brain areas known to be associated with cognitive functions [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Changes in impulsivity following bariatric surgery [ Time Frame: Pre-surgery, 3rd and 12th months after bariatric surgery ]
    Continuous performance task in the PENN-CNP neuropsychological battery and Barratt Impulsivity Scale will be used to assess impulsivity. While continuous performance task assess impulsivity by a computer-based task, Baratt Impulsivity measure is a self-report measure. Therefore, both methods are significant in assessment of impulsivity.

  2. Success of surgery [ Time Frame: 3rd and 12th months after bariatric surgery ]
    Percentage of weight loss proportional to baseline weight measurements

  3. Changes in inflammator factors following bariatric surgery [ Time Frame: Pre-surgery, 3rd and 12th months after bariatric surgery ]
    Blood samples will be obtained from patients to analyze inflammatory markers such as IL-1, IL-6 and TNF-a levels.

  4. Changes in GLP1 will be analyzed following bariatric surgery [ Time Frame: Pre-surgery, 3rd and 12th months after bariatric surgery ]
    Blood samples will be obtained from patients to analyze GLP1 levels.

  5. Changes in social cognition following bariatric surgery [ Time Frame: Pre-surgery, 3rd and 12th months after bariatric surgery ]
    Emotion Recognition Task in the PENN-CNP neuropsychological battery will be used to assess social cognition. Participants see series of 40 faces and are asked to determine the emotion the faces are showing in each trial. There are five different choices: happy, sad, anger, fear and no emotion. The scoring is based on the number of correct responses for each emotion and the number of correctly identified mild and intense emotion expressions. Median response times are also calculated.

  6. Changes in reward learning following bariatric surgery [ Time Frame: Pre-surgery, 3rd and 12th months after bariatric surgery ]
    PRT is used to examine the changes in the reward learning systems after bariatric surgery. It is a signal detection task used for measuring hedonic capacity and reward learning based on monetary reward enhancement. PRT is an objective assessment of the participants' tendency to modulate their behavior in relation to the prize.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For obese patient group:

Inclusion Criteria:

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

Exclusion Criteria:

  1. Dementia
  2. Individuals with severe mental retardation and marked cognitive impairments
  3. Psychotic disorders
  4. Psychoactive substance addiction diagnosis

For healthy volunteers:

Inclusion criteria:

  1. Be between the ages of 18-65
  2. To be able to give informed consent
  3. To be in normal range for BMI
  4. To be observed as in the normal mental status examination

Exclusion criteria:

  1. Dementia
  2. Individuals with severe mental retardation and marked cognitive impairments
  3. Psychotic disorders
  4. Psychoactive substance addiction diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528044


Contacts
Layout table for location contacts
Contact: Ihsan Solaroglu, MD +90 (212) 338 10 39 isolaroglu@ku.edu.tr
Contact: Yunus Yavuz, MD dr.yunusyavuz@gmail.com

Locations
Layout table for location information
Turkey
Fatih Sultan Mehmed Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: Seda Sancak, MD    +90 (532) 664 46 79    drsedasancak@gmail.com   
Koc University School of Medicine Recruiting
Istanbul, Turkey
Contact: Hale Yapici Eser, MD, PHD    +90 (537) 500 24 27    hyapici@ku.edu.tr   
Contact: Derya S Uymaz, MD    +90 (532) 508 26 34    deryauymaz@gmail.com   
Sub-Investigator: Candan Y Eren, PHD Student         
Sub-Investigator: Özge Kılıç, MD         
Marmara University Pendik Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: Samet Yardimci, MD    +90 (507) 365 27 93    sametyardimci@yahoo.com   
Contact: Aylin Erdim, PHD       aerdim@gmail.com   
Sponsors and Collaborators
Koç University
Fatih Sultan Mehmet Training and Research Hospital
Marmara University
Investigators
Layout table for investigator information
Principal Investigator: Hale Yapici Eser, MD, PHD Koc University School of Medicine
Publications:
Dommes, E., & Georgiewa, P. Grey Matter Volume Differences In Obese As Compared to Normal-Weight Individuals: A Voxel-Based Morphometric Study. Archiv Euromedica, 3(2): 11-16, 2013.
Levin RL, Heller W, Mohanty A, Herrington JD, Miller GA. Cognitive deficits in depression and functional specificity of regional brain activity. Cognitive Therapy and Research. 31:211- 233, 2007.

Layout table for additonal information
Responsible Party: Koç University
ClinicalTrials.gov Identifier: NCT03528044    
Other Study ID Numbers: KocU Bari
2017.081.IRB1.011 ( Other Identifier: Koc University IRB )
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Koç University:
Bariatric surgery
Reward
Cognition
Working memory
Grey matter
GLP-1
Inflammation
Stress
Follow-up
Psychiatric
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Impulsive Behavior
Cognition Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Neurocognitive Disorders
Mental Disorders