Diabetes MellitusNCT05492305
Glucagon-like Peptide 1 (GLP1) Receptor Agonists and Mental Health
An observational study of Diabetes Mellitus and Obesity, run by King's College London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Obesity, Mental Health Issue
- What is being tested?
- GLP-1 receptor agonist
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2022to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- not able to consent, speak and read in fluent English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Piya Sen Gupta
About this study
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
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
- Being tested
- GLP-1 receptor agonist
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 receptor agonistDrug
Treatment with any GLP1 receptor agonist e.g. liraglutide, semaglutide, dulaglutide for either obesity or type 2 diabetes mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12-16 weeks
Secondary outcomes (6)
subjective effect of GLP1 receptor agonist on general wellbeing
qualitative analysis of the subjective effect of GLP1 receptor agonist on general wellbeing (determined at stage 2 using the semi-structured interview)
Measured: 12-16 weeks
subjective effect of GLP1 receptor agonist on eating behaviours
qualitative analysis of the subjective effect of GLP1 receptor agonist on eating behaviours (determined at stage 2 using the semi-structured interview)
Measured: 12-16 weeks
subjective effect of GLP1 receptor agonist on binge eating, if present
qualitative analysis of the subjective effect of GLP1 receptor agonist on binge eating, if present (determined at stage 2 using the semi-structured interview)
Measured: 12-16 weeks
mean change in patient health questionnaire 9 (PHQ9) score with GLP1 receptor agonist over 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.
Measured: 12-16 weeks
mean change in generalised anxiety disorder assessment (GAD) score with GLP1 receptor agonist over 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.
Measured: 12-16 weeks
mean change in eating disorder examination questionnaire (EDE-Q) score with GLP1 receptor agonist over 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
Measured: 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aureliane Pierret, King's College London
- Investigators
- Khalida Ismail, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492305
- Sponsor's protocol ID
- 314639
- Status last verified
- Sep 2022
- First submitted
- 3 Aug 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05492305
- Acronym / sponsor ID
- 314639
- Conditions
- Diabetes Mellitus, Obesity, Mental Health Issue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- not able to consent, speak and read in fluent English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 receptor agonistTreatment with any GLP1 receptor agonist e.g. liraglutide, semaglutide, dulaglutide for either obesity or type 2 diabetes mellitus | Drug | – |
Primary outcome
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)
6 secondary outcomes
subjective effect of GLP1 receptor agonist on general wellbeing
Time frame: 12-16 weeks
subjective effect of GLP1 receptor agonist on eating behaviours
Time frame: 12-16 weeks
subjective effect of GLP1 receptor agonist on binge eating, if present
Time frame: 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 generalised anxiety disorder assessment (GAD) score with GLP1 receptor agonist over 12-16 weeks
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalida Ismail principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Obesity, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aureliane Chantal S Pierret (+44(0)2071887188, aureliane.pierret@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective effect of GLP1 receptor agonist on mental health (time frame: 12-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.