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Completed

NCT Number: NCT01043770

The Reversal Intervention for Metabolic Syndrome Study

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.

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Key information

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leicester

Leicester, LE9 6PE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Group lifestyle education

Behavioral

Structured group education programme based on lifestyle changes (dietary and increased physical activity)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Changes in Framingham risk score

    Time frame: Compared at baseline versus 12 months, and for the intervention group versus the control group

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • University Hospitals, Leicester

Registry information

Official study title

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

Acronym: TRIMS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2010
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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