Metabolic SyndromeTRIMSNCT01043770
The Reversal Intervention for Metabolic Syndrome Study
A study testing Group lifestyle education in people with Metabolic Syndrome, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The aim of our study is to see if people with metabolic syndrome who attend a group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes, heart disease and strokes in the future. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Group lifestyle education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Aug 2011
- Phase
- Interventional
- 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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40 - 74 years inclusive
- Registered with a general practice in Leicester City or Leicester County Primary Care Trust
- Availability of data to allow diagnosis of MetS (IDF criteria) collected at a screening visit
Who cannot join
- Previous diagnosis of T2DM, CVD (stroke/cerebrovascular accident, transient ischaemic attack), peripheral arterial disease, or coronary heart disease (angina, myocardial infarction, coronary artery bypass surgery, angioplasty)
- Life-limiting terminal illness
- Pregnancy and/or breast feeding
- Lack of capacity to give informed consent because of serious mental health problems or learning disability.
- People who are housebound
- Patients residing in nursing/care homes
- Individuals who are unable to speak and understand English. (The intervention will be made appropriate for ethnically diverse populations, but individuals who are unable to understand, speak and read English will be excluded at this stage. However, if the self-management programme is found to be successful we would adapt it for non-English speakers.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial to Investigate the Effects of a Structured Self-management Education Programme for People With Metabolic Syndrome
The aim of our study is to see if people with metabolic syndrome who attend a group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes, heart disease and strokes in the future.
Read the detailed description
People who have a combination of risk factors termed metabolic syndrome are at increased risk of developing diabetes, heart disease and strokes. Metabolic syndrome is a major public health concern requiring urgent action because 25% of the adult UK population fulfil the criteria, and this will increase as people continue to be less active and levels of overweight and obesity rise.
The aim of our study is to see if people with metabolic syndrome who attend a structured group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes and cardiovascular disease in the future. Overall, we hope to show that this type of education reduces the number of people who have metabolic syndrome.
Subjects recruited with metabolic syndrome will be randomised to intervention or control arms. The intervention arm will receive group education and the control group will receive routine care.
The results will inform primary prevention strategies in people from varied ethnic backgrounds who are at high risk of developing type-2 diabetes and cardiovascular disease.
- Conditions
- Metabolic Syndrome
- Being tested
- Group lifestyle education
- Keywords
- Metabolic syndrome, Primary prevention, Diabetes, Cardiovascular disease, Patient education
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group lifestyle educationBehavioural
Structured group education programme based on lifestyle changes (dietary and increased physical activity)
| Study group | Role | What they receive |
|---|---|---|
| Group lifestyle education | Experimental | Multi-component behaviour change intervention Receives: Behavioral: Group lifestyle education |
| Routine care | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of people in the intervention and control groups with prevalent metabolic syndrome according to the IDF criteria.
Measured: 12 months follow-up.
Secondary outcomes (9)
The prevalence of metabolic syndrome according to NCEP criteria
Measured: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in individual components of the metabolic syndrome (fasting plasma glucose, triglycerides, HDL cholesterol, blood pressure, waist circumference), and 2 hour glucose
Measured: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in biomarkers (hs-CRP, adiponectin, and insulin)
Measured: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in physical activity as measured by IPAQ and pedometer
Measured: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in dietary/nutritional intake measured by DINE
Measured: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in Framingham risk score
Measured: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in quality of life as measured by EuroQol EQ-5D
Measured: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in depression/anxiety as measured by HADS
Measured: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in general self-efficacy as measured by GSE
Measured: Compared at baseline versus 12 months, and for the intervention group versus the control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Kamlesh Khunti, MD, FRCGP, Principal investigator, Diabetes Research Centre, University of LeicesterMelanie J Davies, MD, FRCP, Principal investigator, Diabetes Research Centre, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043770
- Sponsor's protocol ID
- 0025
- Acronym
- TRIMS
- Status last verified
- Dec 2011
- First submitted
- 6 Jan 2010
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Dunkley AJ, Davies MJ, Stone MA, Taub NA, Troughton J, Yates T, Khunti K. The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data. Trials. 2011 May 4;12:107. doi: 10.1186/1745-6215-12-107.
PubMed 21542913
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Investigate the Effects of a Structured Self-management Education Programme for People With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01043770
- Acronym / sponsor ID
- TRIMS / 0025
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, Primary prevention, Diabetes, Cardiovascular disease, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Jan 2010 (estimated)
- 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.
The aim of our study is to see if people with metabolic syndrome who attend a group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes, heart disease and strokes in the future.
Detailed description
People who have a combination of risk factors termed metabolic syndrome are at increased risk of developing diabetes, heart disease and strokes. Metabolic syndrome is a major public health concern requiring urgent action because 25% of the adult UK population fulfil the criteria, and this will increase as people continue to be less active and levels of overweight and obesity rise.
The aim of our study is to see if people with metabolic syndrome who attend a structured group education programme based on lifestyle changes (dietary and increased physical activity) can lessen their risk of having diabetes and cardiovascular disease in the future. Overall, we hope to show that this type of education reduces the number of people who have metabolic syndrome.
Subjects recruited with metabolic syndrome will be randomised to intervention or control arms. The intervention arm will receive group education and the control group will receive routine care.
The results will inform primary prevention strategies in people from varied ethnic backgrounds who are at high risk of developing type-2 diabetes and cardiovascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group lifestyle education | Experimental | Behavioral: Group lifestyle educationMulti-component behaviour change intervention |
| Routine care | No intervention | –Routine care |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 40 - 74 years inclusive
- Registered with a general practice in Leicester City or Leicester County Primary Care Trust
- Availability of data to allow diagnosis of MetS (IDF criteria) collected at a screening visit
Key exclusion criteria (7 listed)
- Previous diagnosis of T2DM, CVD (stroke/cerebrovascular accident, transient ischaemic attack), peripheral arterial disease, or coronary heart disease (angina, myocardial infarction, coronary artery bypass surgery, angioplasty)
- Life-limiting terminal illness
- Pregnancy and/or breast feeding
- Lack of capacity to give informed consent because of serious mental health problems or learning disability.
- People who are housebound
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 |
|---|---|---|
| Group lifestyle educationStructured group education programme based on lifestyle changes (dietary and increased physical activity) | Behavioural | Group lifestyle education |
Primary outcome
The proportion of people in the intervention and control groups with prevalent metabolic syndrome according to the IDF criteria.
Time frame: 12 months follow-up.
9 secondary outcomes
The prevalence of metabolic syndrome according to NCEP criteria
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in individual components of the metabolic syndrome (fasting plasma glucose, triglycerides, HDL cholesterol, blood pressure, waist circumference), and 2 hour glucose
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in biomarkers (hs-CRP, adiponectin, and insulin)
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in physical activity as measured by IPAQ and pedometer
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in dietary/nutritional intake measured by DINE
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in Framingham risk score
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in quality of life as measured by EuroQol EQ-5D
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in depression/anxiety as measured by HADS
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Changes in general self-efficacy as measured by GSE
Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group
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 30 Jan 2020.
- Results publication: PubMed 21542913Dunkley AJ, Davies MJ, Stone MA, Taub NA, Troughton J, Yates T, Khunti K. The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data. Trials. 2011 May 4;12:107. doi: 10.1186/1745-6215-12-107.
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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.
Kamlesh Khunti, MD, FRCGP principal investigator
Diabetes Research Centre, University of Leicester
Melanie J Davies, MD, FRCP principal investigator
Diabetes Research Centre, University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group lifestyle education in people with Metabolic Syndrome, run by University of Leicester 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 7 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 30 Jan 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?
The proportion of people in the intervention and control groups with prevalent metabolic syndrome according to the IDF criteria. (time frame: 12 months follow-up.). 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 NCT01043770, which also lists 1 linked publication.
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 30 Jan 2020.