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临床试验/NCT05492305
NCT05492305招募中不适用

Effect of Glucagon-like Peptide 1 (GLP1) Receptor Agonists on Mental Health in Patients With Obesity and Type 2 Diabetes (T2D): a Mixed Methods Study

King's College London1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
subjective effect of GLP1 receptor agonist on mental health

研究概览

简要总结

This study is investigating the effect of a medication called glucagon-like peptide 1 (GLP1) receptor agonists on mental health. GLP1 receptor agonists are a type of medication that are used to treat obesity and type 2 diabetes (T2D). Obesity and T2D are very common health conditions, and research has shown that people living with obesity and T2D are more likely to experience mental health disorders. Some recent research has suggested that GLP1 receptor agonists might help with mental health problems such as depression and binge eating disorder, and the investigators want to expand on this in this study. The investigators will be recruiting patients from community diabetes services, and tier 3 weight management services in South East London. Patients will be eligible if they are starting on GLP1 receptor agonists for the management of either T2D or obesity. The study is a mixed methods, longitudinal observations study with two components - a quantitative and a qualitative aspect. Firstly, the investigators will be interviewing patients before and 12-16 weeks after starting the medication, using short questionnaires which asks participants about different mental health symptoms that they may be experiencing. The investigators will use this information to see if there are any objective changes in mental health after taking GLP1 receptor agonists. Secondly, the investigators will be conducting a longer semi-structured interview after the second set of short questionnaires (at 12-16 weeks after starting GLP1 receptor agonist), asking about patient's experiences of taking the medication and how it has affected their mental health and general wellbeing. The investigators will qualitatively analyse this data to determine the subjective effect of GLP1 receptor agonists on mental health and wellbeing.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • being commenced on a glucagon-like peptide 1 (GLP1) receptor agonist for management of either for obesity or type 2 diabetes
  • least 18 years of age
  • able to consent, speak and read in fluent English.

排除标准

  • not able to consent, speak and read in fluent English

结局指标

主要结局

subjective effect of GLP1 receptor agonist on mental health

时间窗: 12-16 weeks

qualitative analysis of the subjective effect of GLP1 receptor agonist on mental health in patients with diabetes and obesity (determined at stage 2 using the semi-structured interview)

次要结局

  • subjective effect of GLP1 receptor agonist on general wellbeing(12-16 weeks)
  • subjective effect of GLP1 receptor agonist on binge eating, if present(12-16 weeks)
  • mean change in eating disorder examination questionnaire (EDE-Q) score with GLP1 receptor agonist over 12-16 weeks(12-16 weeks)
  • mean change in generalised anxiety disorder assessment (GAD) score with GLP1 receptor agonist over 12-16 weeks(12-16 weeks)
  • subjective effect of GLP1 receptor agonist on eating behaviours(12-16 weeks)
  • mean change in patient health questionnaire 9 (PHQ9) score with GLP1 receptor agonist over 12-16 weeks(12-16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aureliane Pierret

Principle investigator

King's College London

研究点 (1)

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