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Идёт набор NCT07411222

Emotional Eating, Sleep Quality, Mental State and Metabolic Syndrome

— Наблюдательное Schizophrenia Bipolar Disorder Psychiatric Issue Metabolic Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Schizophrenia, Bipolar Disorder, Psychiatric Issue, Metabolic Syndrome. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Mediating Role of Emotional Eating and Sleep Quality in the Relationship Between Mental State and Metabolic Syndrome in Individuals With Schizophrenia and Bipolar Disorder

Обзор

In predominantly medication-naïve schizophrenic patients, those exhibiting partial metabolic disorders have significantly worse sleep quality and sleep onset time; poor sleep predicted metabolic dysregulation even after controlling for confounding factors. Mental health, sleep, and eating behavior interact in ways that strongly influence the risk of obesity and MetS. Emotional eating (eating in response to emotions rather than hunger) is central to this network and appears to be closely associated with psychiatric illnesses, particularly depression, anxiety, and sleep disorders. There is a continuing need to elucidate the frequency, level, and relationship of emotional eating with other factors in individuals with SMI. Therefore, this study aims to elucidate this complex relationship, thereby shedding light on new ways to reduce metabolic risks in psychiatric patients.

Подробное описание

Research Questions

* Is there a relationship between mental status and MetS in individuals with SMI? * How does diagnosis (schizophrenia or bipolar disorder) and the group of medications used affect MetS in individuals with SMI? * What is the level of emotional eating in individuals with SMI? * Do emotional eating and sleep quality affect MetS in relation to mental status in individuals with SMI?

Hypotheses

H1 The group of psychotropic medications routinely used significantly affects MetS levels.

H2 Individuals with SMI have high levels of emotional eating.

H3 As mental status deteriorates, the level of emotional eating increases.

H4 Emotional eating mediates the relationship between mental status and MetS.

H5 Sleep quality mediates the relationship between mental status and MetS.

H6 Emotional eating and sleep quality mediate the relationship between mental status and MetS (multiple mediation model).

H7 As sleep quality decreases, emotional eating increases.

H8 As the level of emotional eating increases, sleep quality deteriorates, which increases the risk of metabolic syndrome.

Первичные конечные точки

  • Metabolic Syndrome Risk [Срок оценки: Baseline]
Вторичные конечные точки (5)
  • Emotional eating level [Срок оценки: Baseline]
  • Sleep quality [Срок оценки: Baseline]
  • Positive and negative symptom [Срок оценки: Baseline]
  • Manic symptom [Срок оценки: Baseline]
  • Depressive symptoms [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Being registered with the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center,
  • Having a severe chronic psychiatric illness (Schizophrenia Spectrum and Other Psychotic Disorders and Bipolar Disorder) followed by the Bolu İzzet Baysal Mental Health and Diseases Hospital Community Mental Health Center for at least 6 months,
  • Being in remission (Complete Remission (Pre-Remission): Symptoms remaining below threshold values for at least 2 months (8 weeks). A state of improvement lasting more than 2 months is generally referred to as "remission"),
  • Schizophrenia remission definition: 8 diagnostically significant symptoms were selected from the Positive and Negative Syndrome Scale.
  • Bipolar disorder remission definition: Complete remission is defined as the absence of acute attacks and the presence of minimal/very mild symptoms.
  • Being between 18-65 years of age,
  • Being able to understand what is read and give written consent.

Критерии исключения

  • Having a diagnosis of mental retardation,
  • Having other neurocognitive disorders, primarily dementia, according to DSM-V (as it can affect the ability to make decisions and give correct answers),
  • Not being able to speak or understand Turkish.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Turkey (Türkiye) · 1 центр
  • Melisa Bulut — Bolu

Публикации

  • Zhang W, Sun Q, Chen B, Basta M, Xu C, Li Y. Insomnia symptoms are associated with metabolic syndrome in patients with severe psychiatric disorders. Sleep Med. 2021 Jul;83:168-174. doi: 10.1016/j.sleep.2021.03.030. Epub 2021 May 19. PMID 34022493
  • Zeron-Rugerio MF, Doblas-Faxeda S, Diez-Hernandez M, Izquierdo-Pulido M. Are Emotional Eating and Other Eating Behaviors the Missing Link in the Relationship between Inadequate Sleep and Obesity? A Systematic Review. Nutrients. 2023 May 12;15(10):2286. doi: 10.3390/nu15102286. PMID 37242168
  • Yan H, Huang Z, Lu Y, Qiu Y, Li M, Li J. Associations between metabolic disorders and sleep disturbance in patients with schizophrenia. Compr Psychiatry. 2023 Apr;122:152369. doi: 10.1016/j.comppsych.2023.152369. Epub 2023 Jan 21. PMID 36702060
  • Leutner M, Dervic E, Bellach L, Klimek P, Thurner S, Kautzky A. Obesity as pleiotropic risk state for metabolic and mental health throughout life. Transl Psychiatry. 2023 May 30;13(1):175. doi: 10.1038/s41398-023-02447-w. PMID 37248222
  • Laaboub N, Dubath C, Ranjbar S, Sibailly G, Grosu C, Piras M, Delessert D, Richard-Lepouriel H, Ansermot N, Crettol S, Vandenberghe F, Grandjean C, Delacretaz A, Gamma F, Plessen KJ, von Gunten A, Conus P, Eap CB. Insomnia disorders are associated with increased cardiometabolic disturbances and death risks from cardiovascular diseases in psychiatric patients treated with weight-gain-inducing psych PMID 35581641
  • Dakanalis A, Mentzelou M, Papadopoulou SK, Papandreou D, Spanoudaki M, Vasios GK, Pavlidou E, Mantzorou M, Giaginis C. The Association of Emotional Eating with Overweight/Obesity, Depression, Anxiety/Stress, and Dietary Patterns: A Review of the Current Clinical Evidence. Nutrients. 2023 Feb 26;15(5):1173. doi: 10.3390/nu15051173. PMID 36904172
  • Godet A, Fortier A, Bannier E, Coquery N, Val-Laillet D. Interactions between emotions and eating behaviors: Main issues, neuroimaging contributions, and innovative preventive or corrective strategies. Rev Endocr Metab Disord. 2022 Aug;23(4):807-831. doi: 10.1007/s11154-021-09700-x. Epub 2022 Jan 4. PMID 34984602

Идентификаторы

NCT: NCT07411222 · AIBU-PSK-MB-04

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗