Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes

Study Overview
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Brief Summary
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Intensive lifestyle intervention has shown to be effective in high risk patient populations and has gathered support from leaders-as outlined in the 2015 consensus paper by the Cardiometabolic Health Alliance. Thus there has been a call to establish new care models that assist Metabolic Syndrome patients in reducing there risk. The investigators aim to evaluate the impact of a lifestyle intervention program on metabolic syndrome patients.

Official Title
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CardiOmetabolic SyndroME Response to Therapeutic lIfestyle Changes

Conditions
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Metabolic Syndrome, ASCVD, Lifestyle Risk Reduction

Intervention / Treatment
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* Other: lifestyle modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metabolic syndrome patients meeting 3 of 5 criteria: waist circumference (37 in) in white and AA men, (35 in) in Asian men, and (31.5 in) in women; triglycerides ≥150 mg/dl; high-density lipoprotein cholesterol (HDL-C) <40 mg/dl in men and <50 mg/dl in women; blood pressure ≥130/85 mm Hg fasting glucose ≥100 mg/d or HgbA1c ≥ 5.71 (includes diabetics) Patients requiring secondary ASCD prevention Exclusion Criteria: Patients with less than 5 year survival Patients with cancer undergoing therapy or on palliative treatment Patients with end stage heart failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observation<br>lifestyle modification: nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization | Other: lifestyle modification<br>* nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversal of metabolic syndrome | Change in number of metabolic syndrome risk factors | At the end of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | KM curve of patients with change in metabolic risk factors vs those with no change | within three to five years of intervention | 
| hemoglobin A1c | change in hemoglobin A1c (percentage) | At the end of 12 months | 
| waist circumference | change in waist circumference (inches) | At the end of 12 months | 
| blood pressure | change in average blood pressure (mmHg) | At the end of 12 months | 
| total cholesterol | change in total cholesterol (mg/dL) | At the end of 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiometabolic clinic