The Reversal Intervention for Metabolic Syndrome Study

Metabolic Syndrome Clinical Trial

— TRIMS  

Official title:

A Randomised Controlled Trial to Investigate the Effects of a Structured Self-management Education Programme for People With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043770
• Other study ID #: 0025
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: December 2011
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• Group lifestyle education
Structured group education programme based on lifestyle changes (dietary and increased physical activity)

Locations

Country	Name	City	State
United Kingdom	University of Leicester	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of people in the intervention and control groups with prevalent metabolic syndrome according to the IDF criteria.		12 months follow-up.
Secondary	The prevalence of metabolic syndrome according to NCEP criteria		Compared at baseline versus 12 months, and for the intervention group versus the control group
Secondary	Changes in individual components of the metabolic syndrome (fasting plasma glucose, triglycerides, HDL cholesterol, blood pressure, waist circumference), and 2 hour glucose		Compared at baseline versus 12 months, and for the intervention group versus the control group
Secondary	Changes in biomarkers (hs-CRP, adiponectin, and insulin)		Compared at baseline versus 12 months, and for the intervention group versus the control group
Secondary	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
Secondary	Changes in dietary/nutritional intake measured by DINE		Compared at baseline versus 12 months, and for the intervention group versus the control group
Secondary	Changes in Framingham risk score		Compared at baseline versus 12 months, and for the intervention group versus the control group
Secondary	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
Secondary	Changes in depression/anxiety as measured by HADS		Compared at baseline versus 12 months, and for the intervention group versus the control group
Secondary	Changes in general self-efficacy as measured by GSE		Compared at baseline versus 12 months, and for the intervention group versus the control group