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临床试验/NCT03528044
NCT03528044已完成不适用

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

Koç University3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
3
主要终点
Changes in working memory following bariatric surgery

研究概览

简要总结

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.

详细描述

Aim 1: To assess the psychiatric symptom profiles in the group of obese patient candidates applying for bariatric surgery and to determine the associated environmental stress factors.

Patients will be evaluated with psychosocial scales as part of their pre-surgery assessments. The first psychosocial evaluation of the patients will be performed by a structured clinical interview (SCID) by Dr. Hale Yapici Eser, Dr. Özge Kılıç and then, the participants will be asked to fill in the self-assessment scales and they will be applied some computer based cognitive tests via the assistance of Candan Yasemin Eren.

Scales used to model environmental factors:

  1. Sociodemographic Data Form
  2. Childhood Trauma Questionnaire
  3. Chronic Stress Scale
  4. Perceived Stress Scale
  5. Distress Thermometer
  6. Multidimensional Scale of Perceived Social Support

Scales used to evaluate psychiatric symptom profile: 7. Beck Depression Scale 8. Beck Anxiety Scale 9. Barratt Impulsivity Scale 10. Cognitive Failures Questionnaire 11. Mood Disorder Questionnaire 12. Yale Food Addiction Scale 13. Relationship Scales Questionnaire 14. Difficulties in Emotion Regulation Scale 15. Snaith-Hamilton Pleasure Scale

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For obese patient group:
  • Inclusion Criteria:
  • Be between the ages of 18-65
  • To be able to give informed consent
  • Be a candidate for bariatric surgery.

排除标准

  • Individuals with severe mental retardation and marked cognitive impairments
  • Psychotic disorders
  • Psychoactive substance addiction diagnosis
  • For healthy volunteers:
  • Inclusion criteria:
  • 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
  • Exclusion criteria:
  • Individuals with severe mental retardation and marked cognitive impairments
  • Psychotic disorders
  • Psychoactive substance addiction diagnosis

结局指标

主要结局

Changes in working memory following bariatric surgery

时间窗: 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.

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

时间窗: 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.

次要结局

  • 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)
  • 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 reward learning following bariatric surgery(Pre-surgery, 3rd and 12th months after bariatric surgery)
  • Changes in inflammator factors following bariatric surgery(Pre-surgery, 3rd and 12th months after bariatric surgery)

研究者

发起方
Koç University
申办方类型
Other
责任方
Sponsor

研究点 (3)

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