The Reversal Intervention for Metabolic Syndrome Study (TRIMS)

This study has been completed.
Sponsor:
Collaborator:
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Leicester
ClinicalTrials.gov Identifier:
NCT01043770
First received: January 6, 2010
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Behavioral: Group lifestyle education
Other: Routine care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial to Investigate the Effects of a Structured Self-management Education Programme for People With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Leicester:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in Framingham risk score [ Time Frame: Compared at baseline versus 12 months, and for the intervention group versus the control group ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: August 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle education Behavioral: Group lifestyle education
Structured group education programme based on lifestyle changes (dietary and increased physical activity)
No Intervention: Routine care Other: Routine care
The control group will not receive an intervention and will be asked to see their GP for usual care.

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

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043770

Locations
United Kingdom
University of Leicester
Leicester, United Kingdom, LE9 6PE
Sponsors and Collaborators
University of Leicester
University Hospitals, Leicester
Investigators
Principal Investigator: Kamlesh Khunti, MD, FRCGP Department of Health Sciences, University of Leicester
Principal Investigator: Melanie J Davies, MD, FRCP Department of Cardiovascular Sciences, University of Leicester
  More Information

No publications provided by University of Leicester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT01043770     History of Changes
Other Study ID Numbers: UoL-08-H0402-142
Study First Received: January 6, 2010
Last Updated: December 13, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Leicester:
Metabolic syndrome
Primary prevention
Diabetes
Cardiovascular disease
Patient education

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014