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临床试验/ISRCTN14809377
ISRCTN14809377进行中(未招募)未知

Studying the psychological and interoceptive contributions to eating

niversity of Cambridge0 个研究点目标入组 270 人开始时间: 2021年5月28日最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
270

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

性别
All

入选标准

  • All participants:
  • 1. Aged 18-45 years
  • 2. Written informed consent given
  • 3. Estimated IQ =80 measured using the WASI-II Full Scale-2
  • 4. Ambulatory
  • 5. Normal or corrected-to-normal vision
  • Gastrectomy patient group:
  • 1. Aged 18-60 years
  • 2. If post-operative, clinically stable
  • Monogenic obesity patient group:
  • 1. Identified mutation in MC4R, LepR, or SIM1 genes

排除标准

  • All participants:
  • 1. Not fluent English speaker
  • 2. Current serious neurological or psychiatric illness, including neurodevelopmental disorders; schizophrenia spectrum and other psychotic disorders; bipolar and related disorders; substance-related and addictive disorders; obsessive-compulsive and related disorders; anorexia nervosa, bulimia nervosa, binge-eating disorder, or otherwise specified feeding or eating disorder; previous bariatric or gastric bypass (Roux-en-Y) surgery
  • 3. Type 1 or Type 2 diabetes
  • 4. Evidence of anaemia, metabolic or cardiovascular disease, or disease that may influence metabolism or blood measurements (such as cancer or thyroid disease)
  • 5. Dietary restrictions that cannot be accommodated by the metabolic kitchen
  • 6. Pregnancy or lactation
  • 7. Contraindications to MRI scanning (such as pacemakers, metallic prostheses such as cochlear implants or heart valves, or shrapnel fragments)
  • 8. Claustrophobic to a degree that they would feel uncomfortable in the MRI scanner
  • Lean group:
  • 1. Left-handedness
  • 2. BMI outside of the range 18.5-24.9 kg/m²
  • 3. Lifetime history of any of the following DSM-5 psychiatric conditions:
  • 3.1. Obsessive-Compulsive and Related Disorders
  • 3.2. Trauma- and Stressor-Related Disorders
  • 3.3. Dissociative Disorders
  • 3.4. Somatic Symptom and Related Disorders
  • 3.5. Disruptive, Impulse-Control, and Conduct Disorders
  • 4. Recent history (previous 6 months) of any of the following DSM-5 psychiatric conditions
  • 4.1. Depressive Disorders
  • 4.2. Anxiety Disorders
  • 5. Current use of antidepressant or anxiolytic medication
  • Diet-induced obesity group:
  • 1. Left-handedness
  • 2. BMI <29.9 kg/m²
  • 3. Lifetime history of any of the following DSM-5 psychiatric conditions:
  • 3.1. Obsessive-Compulsive and Related Disorders
  • 3.2. Trauma- and Stressor-Related Disorders
  • 3.3. Dissociative Disorders
  • 3.4. Somatic Symptom and Related Disorders
  • 3.5. Disruptive, Impulse-Control, and Conduct Disorders
  • 4. Recent history (previous 6 months) of any of the following DSM-5 psychiatric conditions
  • 4.1. Depressive Disorders
  • 4.2. Anxiety Disorders
  • 5. Current use of antidepressant or anxiolytic medication
  • Gastrectomy and monogenic obesity patient groups:
  • 1. Treating clinician has any concerns that participation in the study may have a deleterious effect on the participant’s health or ongoing treatment

研究者

发起方
niversity of Cambridge

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