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| Name | Class |
|---|---|
| University Hospitals, Leicester | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group lifestyle education | Experimental | Multi-component behaviour change intervention |
|
| Routine care | No Intervention | Routine care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group lifestyle education | Behavioral | Structured group education programme based on lifestyle changes (dietary and increased physical activity) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of people in the intervention and control groups with prevalent metabolic syndrome according to the IDF criteria. | 12 months follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of metabolic syndrome according to NCEP criteria | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamlesh Khunti, MD, FRCGP | Diabetes Research Centre, University of Leicester | Principal Investigator |
| Melanie J Davies, MD, FRCP | Diabetes Research Centre, University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leicester | Leicester | LE9 6PE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21542913 | Result | 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. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Compared at baseline versus 12 months, and for the intervention group versus the control group |
| Changes in biomarkers (hs-CRP, adiponectin, and insulin) | 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 | Compared at baseline versus 12 months, and for the intervention group versus the control group |
| Changes in dietary/nutritional intake measured by DINE | Compared at baseline versus 12 months, and for the intervention group versus the control group |
| Changes in Framingham risk score | 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 | Compared at baseline versus 12 months, and for the intervention group versus the control group |
| Changes in depression/anxiety as measured by HADS | Compared at baseline versus 12 months, and for the intervention group versus the control group |
| Changes in general self-efficacy as measured by GSE | Compared at baseline versus 12 months, and for the intervention group versus the control group |
| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |