Clinical trial NCT01043770: The Reversal Intervention for Metabolic Syndrome Study
Official title: A Randomised Controlled Trial to Investigate the Effects of a Structured Self-management Education Programme for People With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome
Primary prevention
Diabetes
Cardiovascular disease
Patient education
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2010-01-07
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: The proportion of people in the intervention and control groups with prevalent metabolic syndrome according to the IDF criteria.
timeFrame: 12 months follow-up.
Secondary outcomes:
measure: The prevalence of metabolic syndrome according to NCEP criteria
timeFrame: Compared at baseline versus 12 months, and for the intervention group versus the control group
measure: Changes in individual components of the metabolic syndrome (fasting plasma glucose, triglycerides, HDL cholesterol, blood pressure, waist circumference), and 2 hour glucose
timeFrame: Compared at baseline versus 12 months, and for the intervention group versus the control group
measure: Changes in biomarkers (hs-CRP, adiponectin, and insulin)
timeFrame: Compared at baseline versus 12 months, and for the intervention group versus the control group
measure: Changes in physical activity as measured by IPAQ and pedometer
timeFrame: Compared at baseline versus 12 months, and for the intervention group versus the control group
measure: Changes in dietary/nutritional intake measured by DINE
timeFrame: Compared at baseline versus 12 months, and for the intervention group versus the control group
measure: Changes in Framingham risk score
timeFrame: Compared at baseline versus 12 months, and for the intervention group versus the control group
measure: Changes in quality of life as measured by EuroQol EQ-5D
timeFrame: Compared at baseline versus 12 months, and for the intervention group versus the control group
measure: Changes in depression/anxiety as measured by HADS
timeFrame: Compared at baseline versus 12 months, and for the intervention group versus the control group
measure: Changes in general self-efficacy as measured by GSE
timeFrame: Compared at baseline versus 12 months, and for the intervention group versus the control group
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University of Leicester
Study officials:
affiliation: Diabetes Research Centre, University of Leicester
name: Kamlesh Khunti, MD, FRCGP
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes Research Centre, University of Leicester
name: Melanie J Davies, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.