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

September 22, 2022 updated by: Aureliane Pierret, King's College London

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
          • Piya Sen Gupta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective effect of GLP1 receptor agonist on mental health
Time Frame: 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)
12-16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective effect of GLP1 receptor agonist on general wellbeing
Time Frame: 12-16 weeks
qualitative analysis of the subjective effect of GLP1 receptor agonist on general wellbeing (determined at stage 2 using the semi-structured interview)
12-16 weeks
subjective effect of GLP1 receptor agonist on eating behaviours
Time Frame: 12-16 weeks
qualitative analysis of the subjective effect of GLP1 receptor agonist on eating behaviours (determined at stage 2 using the semi-structured interview)
12-16 weeks
subjective effect of GLP1 receptor agonist on binge eating, if present
Time Frame: 12-16 weeks
qualitative analysis of the subjective effect of GLP1 receptor agonist on binge eating, if present (determined at stage 2 using the semi-structured interview)
12-16 weeks
mean change in patient health questionnaire 9 (PHQ9) score with GLP1 receptor agonist over 12-16 weeks
Time Frame: 12-16 weeks
mean change in PHQ9 score with GLP1 receptor agonist over 12-16 weeks (determined at stage 2 by comparing the questionnaire scores from stages 1 and 2). Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
12-16 weeks
mean change in generalised anxiety disorder assessment (GAD) score with GLP1 receptor agonist over 12-16 weeks
Time Frame: 12-16 weeks
mean change in GAD score with GLP1 receptor agonist over 12-16 weeks (determined at stage 2 by comparing the questionnaire scores from stages 1 and 2). Score between 0 and 21; scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
12-16 weeks
mean change in eating disorder examination questionnaire (EDE-Q) score with GLP1 receptor agonist over 12-16 weeks
Time Frame: 12-16 weeks
mean change in EDE-Q score with GLP1 receptor agonist over 12-16 weeks (determined at stage 2 by comparing the questionnaire scores from stages 1 and 2). Score between 0 and 168, higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes
12-16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

  • Principal Investigator: Khalida Ismail, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 314639

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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