Clinical trial NCT05492305: Glucagon-like Peptide 1 (GLP1) Receptor Agonists and Mental Health
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Obesity
Mental Health Issue
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being commenced on GLP1 receptor agonist for management of either for obesity or type 2 diabetes, according to the NICE guidelines for these indications.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: subjective effect of GLP1 receptor agonist on mental health
timeFrame: 12-16 weeks
Secondary outcomes:
measure: subjective effect of GLP1 receptor agonist on general wellbeing
timeFrame: 12-16 weeks
measure: subjective effect of GLP1 receptor agonist on eating behaviours
timeFrame: 12-16 weeks
measure: subjective effect of GLP1 receptor agonist on binge eating, if present
timeFrame: 12-16 weeks
measure: mean change in patient health questionnaire 9 (PHQ9) score with GLP1 receptor agonist over 12-16 weeks
timeFrame: 12-16 weeks
measure: mean change in generalised anxiety disorder assessment (GAD) score with GLP1 receptor agonist over 12-16 weeks
timeFrame: 12-16 weeks
measure: mean change in eating disorder examination questionnaire (EDE-Q) score with GLP1 receptor agonist over 12-16 weeks
timeFrame: 12-16 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Khalida Ismail
role: PRINCIPAL_INVESTIGATOR
References: