Diabetes Mellitus, Type 2EMERALDNCT03534921
Improving Diabetes Outcomes for People With Severe Mental Illness (SMI)
An observational study of Diabetes Mellitus, Type 2 and Severe Mental Disorder, run by University of York at 1 site in United Kingdom.
Trial summary
This study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with severe mental illness (schizophrenia, schizoaffective disorder and bipolar disorder) in order to develop potential healthcare interventions that can be tested further. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Severe Mental Disorder
- How many people
- 46,564 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 31 Oct 2019
- 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: - Dataset A: patients (with research-quality data) who received a diagnosis of severe mental illness (schizophrenia, schizoaffective disorder and bipolar disorder) at the age of 18 years or above, and who have at least one event of SMI in the study period (01/04/2000-31/03/2016) Dataset B: patients drawn from Dataset A who also have a diagnosis of type 2 diabetes mellitus (received on/after the age of 18). Dataset C: patients with diabetes but no diagnosis of severe mental illness matched to Dataset B on a ratio of 4:1 on the basis of age (+-2 years), gender and GP practice.
Who may be able to join
- Patients aged 18 and over
- Patients with diagnoses of severe mental illness, severe mental illness and type 2 diabetes, or with diabetes but no diagnosis of severe mental illness.
- Patients with research-quality data.
Who cannot join
- Patients under the age of 18
- Patients without research quality data.
- Patients who were diagnosed with Type 1 diabetes following a diagnosis of Type 2 diabetes.
- Patients who have a code for a diabetic complication (e.g. diabetic retinopathy) but no diagnostic code for diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Diabetes Outcomes for People With Severe Mental Illness (SMI): a Longitudinal Observational and Qualitative Study of Patients in England
This study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with severe mental illness (schizophrenia, schizoaffective disorder and bipolar disorder) in order to develop potential healthcare interventions that can be tested further.
The study utilises a mixed methods design comprising analysis of patient primary care records and interviews with patients living with comorbid SMI and diabetes, family carers and healthcare professionals involved in commissioning or delivering healthcare for this population. This entry on the Protocol Registration and Results System describes only the quantitative Work Package of the study in detail i.e. analysis of patient primary care records.
Read the detailed description
People living with severe mental illness (SMI) have a lower life expectancy (by around 20 years) than the general population, often dying of preventable or manageable illnesses (Woodhead et al., 2014). Diabetes contributes significantly to this health inequality, being 2-3 times more likely in people with SMI (Stubbs et al., 2015). This study aims to understand the determinants of type 2 diabetes and variation in diabetes outcomes for people with SMI in order to identify potential healthcare interventions that can be tested further.
Research questions:
- What are the socio-demographic and illness-related risk factors associated with
- developing type 2 diabetes in people with SMI?
- variation in diabetes and mental health outcomes in people with SMI and type 2 diabetes?
- How do physical and mental health outcomes differ between people with SMI and type 2 diabetes,
- compared to people with SMI without diabetes?
- compared to people with type 2 diabetes but no SMI?
- What factors influence access to, and receipt of, diabetes care for people with SMI, and how are diabetes healthcare interventions experienced by people with SMI?
- How and at what cost is type 2 diabetes monitored and managed in people with SMI compared to those without SMI?
- What healthcare interventions (e.g. medication, referrals and care pathways) are associated with better diabetes outcomes for people with SMI and type 2 diabetes?
The study has the following objectives:
- In people with SMI, to identify which socio-demographic, illness, family history and lifestyle factors are associated with the development of type 2 diabetes.
- In people with SMI and type 2 diabetes, to identify which socio-demographic, illness, family history and lifestyle factors are associated with variation in diabetes and mental health outcomes.
- In people with SMI, to compare healthcare interventions, physical and mental health outcomes in those with type 2 diabetes with those without diabetes.
- In people with type 2 diabetes, to compare healthcare interventions, physical and mental health outcomes in those with SMI and those without SMI.
- To understand the factors that influence access to, and receipt of, diabetes care for people with SMI, and explore the experience of diabetes healthcare by people with SMI.
- To compare diabetes care provision for people with and without SMI, and estimate costs for these.
- To identify which healthcare interventions (e.g. medication, referrals and care pathways) may be associated with better diabetes outcomes for people with SMI and type 2 diabetes.
Study design:
The study will utilise a convergent triangulation mixed methods design comprising a quantitative longitudinal observational study of individual patient records of adults with diagnosed SMI and diabetes held in the Clinical Practice Research Datalink (CPRD, a computerised database of anonymised primary care medical records drawn from a proportion of general practices in the UK) with qualitative interviews with patients, their family carers and healthcare professionals who commission or deliver services to this comorbid population. This entry on the Protocol Registration and Results System describes only the quantitative work stream of the study i.e. the interrogation of patient primary care records. The key healthcare outcomes to be examined are listed; however, a definitive list of outcomes will be agreed through a consensus process with project team members.
The complete study is organised in three work packages:
- Work Package One, which involves ongoing consultation with experts (service users and family members belonging to a Patient and Public Involvement (PPI) panel, healthcare staff and researchers) to refine questions and analyses, a synthesis of evidence on SMI and diabetes risks and outcomes, integrating the qualitative and quantitative studies, conducting co-design workshops to translate study findings into recommendations, and optimising the dissemination of findings.
- Work Package Two, which investigates the role of risk factors thought to influence i) development of type 2 diabetes in people with SMI (objective 1), and ii) variation in health outcomes in people with comorbid SMI and type 2 diabetes (objective 2). Further analyses involve a comparison of diabetes healthcare and outcomes for people with SMI and type 2 diabetes with outcomes for people with either condition alone (objectives 3 and 4), an examination of variations in type 2 diabetes screening, monitoring and management and estimation of the costs for these (objective 6); and an exploration of the role of these interventions in contributing to health outcomes (objective 7). These investigations will utilise the CPRD database, which is linked to other datasets, including Hospital Episode Statistics (HES) data, HES-Office of National Statistics mortality data, and Index of Multiple Deprivation (IMD) data. Three CPRD datasets will be analysed which will consist of linked records from the study period of 01 April 2000 to 31 March 2016. The first of these, Dataset A, will contain records of a cohort of adult patients with a diagnosis of SMI. Dataset B is constructed from Dataset A, and comprises those in Dataset A who also have a diagnosis of diabetes. Finally, Dataset C is a cohort of patients with diabetes but no record of SMI who are age and gender-matched to Dataset B on a ratio of 4:1.
- Work Package Three, which explores the experience of diabetes management and healthcare from three perspectives: patients, family members or friends who support them and healthcare professionals who commission or deliver services.
Dissemination
Findings will be translated into service recommendations through two multi-stakeholder co-design workshops. The first of these will identify further avenues of inquiry for the final stages of analysis and will develop draft recommendations to improve the organisation and delivery of healthcare for this comorbid population. The second workshop will further develop the recommendations based on the final analyses and will design interventions or care pathways, assessing their potential acceptability and feasibility for future evaluation and implementation.
A dissemination event will be held, presenting materials in a range of formats to maximise opportunities for knowledge exchange. Study outputs will include a final report for the funding body, scientific papers submitted to international peer-reviewed journals, short articles in practitioner journals, executive summaries published on websites, conference presentations, and other materials disseminated through clinical, academic and voluntary sector networks.
- Conditions
- Diabetes Mellitus, Type 2, Severe Mental Disorder
- Keywords
- Diabetes mellitus, Schizophrenia, Schizoaffective disorder, Bipolar disorder, Severe mental illness
- Medical subject headings
- Diabetes Mellitus, Type 2, Mental Disorders, Diabetes Mellitus, Schizophrenia, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with severe mental illness (SMI) | In the study period 01/04/2000-31/03/2016, people with records on the Clinical Practice Research Datalink aged >=18 years with a record of severe mental illness so that at least one event occurs in the study period. | |
| People with SMI and type 2 diabetes | Drawn from the first cohort, this group also has a record of type two diabetes mellitus registered during the study period. | |
| People with diabetes (matched controls) | This cohort will be matched on a 4:1 ratio by age (+- 2 years), gender and general practitioner practice to the group of people with comorbid SMI and diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes status
Clinical diagnosis of Type 2 diabetes
Measured: 01/04/2000-31/03/2016
Diabetes onset
Time from diagnosis of SMI to diagnosis of type 2 diabetes
Measured: 01/04/2000-31/03/2016
Diabetic control
Changes in HbA1c
Measured: 01/04/2000-31/03/2016
Cardiovascular control: Blood pressure
Changes in blood pressure
Measured: 01/04/2000-31/03/2016
Cardiovascular control: Lipid profile
Changes in serum cholesterol levels
Measured: 01/04/2000-31/03/2016
Diabetic complications 1: Glucose dysregulation
Hyperglycaemic or hypoglycaemic events
Measured: 01/04/2000-31/03/2016
Diabetic complications 2: Micro-vascular complications
Clinical diagnosis of micro-vascular complications e.g. peripheral neuropathy
Measured: 01/04/2000-31/03/2016
Diabetic complications 3: Macro-vascular complications
Clinical diagnosis of macro-vascular complications e.g. myocardial infarction
Measured: 01/04/2000-31/03/2016
Mental Health Outcomes - Depression
Clinician diagnosis of depression
Measured: 01/04/2000-31/03/2016
Mental Health Outcome - SMI relapse
Clinician diagnosis of SMI relapse
Measured: 01/04/2000-31/03/2016
Mental Health Outcome - Anxiety
Clinical diagnosis of anxiety
Measured: 01/04/2000-31/03/2016
Hospital admissions
Number and type of admissions related to diabetes, severe mental illness or diabetic complications
Measured: 01/04/2000-31/03/2016
Mortality
Patient death
Measured: 01/04/2000-31/03/2016
Healthcare costs
Cost of primary care consultations
Measured: 01/04/2000-31/03/2016
Primary care consultations
The number and type of primary care consultations
Measured: 01/04/2000-31/03/2016
Healthcare interventions - medication use
Prescription of antipsychotic medication, antidepressant medication, antihypertensive medication
Measured: 01/04/2000-31/03/2016
Healthcare interventions - referrals
Referrals for self-management education, diabetes clinics
Measured: 01/04/2000-31/03/2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Apr 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 46,564 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of York
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, University of Southampton
- Responsible party
- Principal investigator, Najma Siddiqi, University of York
- Investigators
- Dr Siddiqi, Principal investigator, University of York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534921
- Sponsor's protocol ID
- 15/70/26
- Acronym
- EMERALD
- Status last verified
- Mar 2020
- First submitted
- 10 Apr 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Woodhead C, Ashworth M, Schofield P, Henderson M. Patterns of physical co-/multi-morbidity among patients with serious mental illness: a London borough-based cross-sectional study. BMC Fam Pract. 2014 Jun 11;15:117. doi: 10.1186/1471-2296-15-117.
PubMed 24919453Stubbs B, Vancampfort D, De Hert M, Mitchell AJ. The prevalence and predictors of type two diabetes mellitus in people with schizophrenia: a systematic review and comparative meta-analysis. Acta Psychiatr Scand. 2015 Aug;132(2):144-57. doi: 10.1111/acps.12439. Epub 2015 May 5.
PubMed 25943829Bellass S, Taylor J, Han L, Prady SL, Shiers D, Jacobs R, Holt RIG, Radford J, Gilbody S, Hewitt C, Doran T, Alderson SL, Siddiqi N. Exploring Severe Mental Illness and Diabetes: Protocol for a Longitudinal, Observational, and Qualitative Mixed Methods Study. JMIR Res Protoc. 2019 Sep 6;8(9):13407. doi: 10.2196/13407.
PubMed 31493324
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Outcomes for People With Severe Mental Illness (SMI): a Longitudinal Observational and Qualitative Study of Patients in England
- ClinicalTrials.gov ID
- NCT03534921
- Acronym / sponsor ID
- EMERALD / 15/70/26
- Conditions
- Diabetes Mellitus, Type 2, Severe Mental Disorder
- Keywords
- Diabetes mellitus, Schizophrenia, Schizoaffective disorder, Bipolar disorder, Severe mental illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46,564 participants (actual)
- Lead sponsor
- University of YorkUniversity, hospital or other
- Collaborators
- University of Leeds, University of Southampton
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 23 May 2018 (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 aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with severe mental illness (schizophrenia, schizoaffective disorder and bipolar disorder) in order to develop potential healthcare interventions that can be tested further.
The study utilises a mixed methods design comprising analysis of patient primary care records and interviews with patients living with comorbid SMI and diabetes, family carers and healthcare professionals involved in commissioning or delivering healthcare for this population. This entry on the Protocol Registration and Results System describes only the quantitative Work Package of the study in detail i.e. analysis of patient primary care records.
Detailed description
People living with severe mental illness (SMI) have a lower life expectancy (by around 20 years) than the general population, often dying of preventable or manageable illnesses (Woodhead et al., 2014). Diabetes contributes significantly to this health inequality, being 2-3 times more likely in people with SMI (Stubbs et al., 2015). This study aims to understand the determinants of type 2 diabetes and variation in diabetes outcomes for people with SMI in order to identify potential healthcare interventions that can be tested further.
Research questions:
- What are the socio-demographic and illness-related risk factors associated with
- developing type 2 diabetes in people with SMI?
- variation in diabetes and mental health outcomes in people with SMI and type 2 diabetes?
- How do physical and mental health outcomes differ between people with SMI and type 2 diabetes,
- compared to people with SMI without diabetes?
- compared to people with type 2 diabetes but no SMI?
- What factors influence access to, and receipt of, diabetes care for people with SMI, and how are diabetes healthcare interventions experienced by people with SMI?
- How and at what cost is type 2 diabetes monitored and managed in people with SMI compared to those without SMI?
- What healthcare interventions (e.g. medication, referrals and care pathways) are associated with better diabetes outcomes for people with SMI and type 2 diabetes?
The study has the following objectives:
- In people with SMI, to identify which socio-demographic, illness, family history and lifestyle factors are associated with the development of type 2 diabetes.
- In people with SMI and type 2 diabetes, to identify which socio-demographic, illness, family history and lifestyle factors are associated with variation in diabetes and mental health outcomes.
- In people with SMI, to compare healthcare interventions, physical and mental health outcomes in those with type 2 diabetes with those without diabetes.
- In people with type 2 diabetes, to compare healthcare interventions, physical and mental health outcomes in those with SMI and those without SMI.
- To understand the factors that influence access to, and receipt of, diabetes care for people with SMI, and explore the experience of diabetes healthcare by people with SMI.
- To compare diabetes care provision for people with and without SMI, and estimate costs for these.
- To identify which healthcare interventions (e.g. medication, referrals and care pathways) may be associated with better diabetes outcomes for people with SMI and type 2 diabetes.
Study design:
The study will utilise a convergent triangulation mixed methods design comprising a quantitative longitudinal observational study of individual patient records of adults with diagnosed SMI and diabetes held in the Clinical Practice Research Datalink (CPRD, a computerised database of anonymised primary care medical records drawn from a proportion of general practices in the UK) with qualitative interviews with patients, their family carers and healthcare professionals who commission or deliver services to this comorbid population. This entry on the Protocol Registration and Results System describes only the quantitative work stream of the study i.e. the interrogation of patient primary care records. The key healthcare outcomes to be examined are listed; however, a definitive list of outcomes will be agreed through a consensus process with project team members.
The complete study is organised in three work packages:
- Work Package One, which involves ongoing consultation with experts (service users and family members belonging to a Patient and Public Involvement (PPI) panel, healthcare staff and researchers) to refine questions and analyses, a synthesis of evidence on SMI and diabetes risks and outcomes, integrating the qualitative and quantitative studies, conducting co-design workshops to translate study findings into recommendations, and optimising the dissemination of findings.
- Work Package Two, which investigates the role of risk factors thought to influence i) development of type 2 diabetes in people with SMI (objective 1), and ii) variation in health outcomes in people with comorbid SMI and type 2 diabetes (objective 2). Further analyses involve a comparison of diabetes healthcare and outcomes for people with SMI and type 2 diabetes with outcomes for people with either condition alone (objectives 3 and 4), an examination of variations in type 2 diabetes screening, monitoring and management and estimation of the costs for these (objective 6); and an exploration of the role of these interventions in contributing to health outcomes (objective 7). These investigations will utilise the CPRD database, which is linked to other datasets, including Hospital Episode Statistics (HES) data, HES-Office of National Statistics mortality data, and Index of Multiple Deprivation (IMD) data. Three CPRD datasets will be analysed which will consist of linked records from the study period of 01 April 2000 to 31 March 2016. The first of these, Dataset A, will contain records of a cohort of adult patients with a diagnosis of SMI. Dataset B is constructed from Dataset A, and comprises those in Dataset A who also have a diagnosis of diabetes. Finally, Dataset C is a cohort of patients with diabetes but no record of SMI who are age and gender-matched to Dataset B on a ratio of 4:1.
- Work Package Three, which explores the experience of diabetes management and healthcare from three perspectives: patients, family members or friends who support them and healthcare professionals who commission or deliver services.
Dissemination
Findings will be translated into service recommendations through two multi-stakeholder co-design workshops. The first of these will identify further avenues of inquiry for the final stages of analysis and will develop draft recommendations to improve the organisation and delivery of healthcare for this comorbid population. The second workshop will further develop the recommendations based on the final analyses and will design interventions or care pathways, assessing their potential acceptability and feasibility for future evaluation and implementation.
A dissemination event will be held, presenting materials in a range of formats to maximise opportunities for knowledge exchange. Study outputs will include a final report for the funding body, scientific papers submitted to international peer-reviewed journals, short articles in practitioner journals, executive summaries published on websites, conference presentations, and other materials disseminated through clinical, academic and voluntary sector networks.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| People with severe mental illness (SMI) | – | –In the study period 01/04/2000-31/03/2016, people with records on the Clinical Practice Research Datalink aged >=18 years with a record of severe mental illness so that at least one event occurs in the study period. |
| People with SMI and type 2 diabetes | – | –Drawn from the first cohort, this group also has a record of type two diabetes mellitus registered during the study period. |
| People with diabetes (matched controls) | – | –This cohort will be matched on a 4:1 ratio by age (+- 2 years), gender and general practitioner practice to the group of people with comorbid SMI and diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Dataset A: patients (with research-quality data) who received a diagnosis of severe mental illness (schizophrenia, schizoaffective disorder and bipolar disorder) at the age of 18 years or above, and who have at least one event of SMI in the study period (01/04/2000-31/03/2016) Dataset B: patients drawn from Dataset A who also have a diagnosis of type 2 diabetes mellitus (received on/after the age of 18). Dataset C: patients with diabetes but no diagnosis of severe mental illness matched to Dataset B on a ratio of 4:1 on the basis of age (+-2 years), gender and GP practice.
Key inclusion criteria (3 listed)
- Patients aged 18 and over
- Patients with diagnoses of severe mental illness, severe mental illness and type 2 diabetes, or with diabetes but no diagnosis of severe mental illness.
- Patients with research-quality data.
Key exclusion criteria (4 listed)
- Patients under the age of 18
- Patients without research quality data.
- Patients who were diagnosed with Type 1 diabetes following a diagnosis of Type 2 diabetes.
- Patients who have a code for a diabetic complication (e.g. diabetic retinopathy) but no diagnostic code for diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diabetes status
Time frame: 01/04/2000-31/03/2016
Clinical diagnosis of Type 2 diabetes
Diabetes onset
Time frame: 01/04/2000-31/03/2016
Time from diagnosis of SMI to diagnosis of type 2 diabetes
Diabetic control
Time frame: 01/04/2000-31/03/2016
Changes in HbA1c
Cardiovascular control: Blood pressure
Time frame: 01/04/2000-31/03/2016
Changes in blood pressure
Cardiovascular control: Lipid profile
Time frame: 01/04/2000-31/03/2016
Changes in serum cholesterol levels
Diabetic complications 1: Glucose dysregulation
Time frame: 01/04/2000-31/03/2016
Hyperglycaemic or hypoglycaemic events
Diabetic complications 2: Micro-vascular complications
Time frame: 01/04/2000-31/03/2016
Clinical diagnosis of micro-vascular complications e.g. peripheral neuropathy
Diabetic complications 3: Macro-vascular complications
Time frame: 01/04/2000-31/03/2016
Clinical diagnosis of macro-vascular complications e.g. myocardial infarction
Mental Health Outcomes - Depression
Time frame: 01/04/2000-31/03/2016
Clinician diagnosis of depression
Mental Health Outcome - SMI relapse
Time frame: 01/04/2000-31/03/2016
Clinician diagnosis of SMI relapse
Mental Health Outcome - Anxiety
Time frame: 01/04/2000-31/03/2016
Clinical diagnosis of anxiety
Hospital admissions
Time frame: 01/04/2000-31/03/2016
Number and type of admissions related to diabetes, severe mental illness or diabetic complications
Mortality
Time frame: 01/04/2000-31/03/2016
Patient death
Healthcare costs
Time frame: 01/04/2000-31/03/2016
Cost of primary care consultations
Primary care consultations
Time frame: 01/04/2000-31/03/2016
The number and type of primary care consultations
Healthcare interventions - medication use
Time frame: 01/04/2000-31/03/2016
Prescription of antipsychotic medication, antidepressant medication, antihypertensive medication
Healthcare interventions - referrals
Time frame: 01/04/2000-31/03/2016
Referrals for self-management education, diabetes clinics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Background: PubMed 24919453Woodhead C, Ashworth M, Schofield P, Henderson M. Patterns of physical co-/multi-morbidity among patients with serious mental illness: a London borough-based cross-sectional study. BMC Fam Pract. 2014 Jun 11;15:117. doi: 10.1186/1471-2296-15-117.
- Background: PubMed 25943829Stubbs B, Vancampfort D, De Hert M, Mitchell AJ. The prevalence and predictors of type two diabetes mellitus in people with schizophrenia: a systematic review and comparative meta-analysis. Acta Psychiatr Scand. 2015 Aug;132(2):144-57. doi: 10.1111/acps.12439. Epub 2015 May 5.
- Derived from this study: PubMed 31493324Bellass S, Taylor J, Han L, Prady SL, Shiers D, Jacobs R, Holt RIG, Radford J, Gilbody S, Hewitt C, Doran T, Alderson SL, Siddiqi N. Exploring Severe Mental Illness and Diabetes: Protocol for a Longitudinal, Observational, and Qualitative Mixed Methods Study. JMIR Res Protoc. 2019 Sep 6;8(9):13407. doi: 10.2196/13407.
- 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.
Dr Siddiqi principal investigator
University of York
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, Type 2 and Severe Mental Disorder, run by University of York 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 4 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: finished, as of the sponsor's last update on 24 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes status (time frame: 01/04/2000-31/03/2016). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534921, which also lists 3 linked publications.
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 24 Mar 2020.