Glucagon-like Peptide 1 (GLP1) Receptor Agonists and Mental Health

NCT05492305 | Unknown

• 1 other identifier: 314639
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Obesity; Mental Health Issue

Outcome Measures

Primary Outcomes (1)

• subjective effect of GLP1 receptor agonist on mental health

  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)

  12-16 weeks

Secondary Outcomes (6)

• subjective effect of GLP1 receptor agonist on general wellbeing

  12-16 weeks

• subjective effect of GLP1 receptor agonist on eating behaviours

  12-16 weeks

• subjective effect of GLP1 receptor agonist on binge eating, if present

  12-16 weeks

• mean change in patient health questionnaire 9 (PHQ9) 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

Interventions

GLP-1 receptor agonist DRUG

Treatment with any GLP1 receptor agonist e.g. liraglutide, semaglutide, dulaglutide for either obesity or type 2 diabetes mellitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Khalida Ismail

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aureliane Chantal S Pierret

CONTACT

+44(0)2071887188; aureliane.pierret@gmail.com

Khalida Ismail

CONTACT

+44(0)2078485131; khalida.2.ismail@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)