ASCVD, Lifestyle Risk Reduction, Metabolic Syndrome
Conditions
Keywords
cardiometabolic clinic
Brief summary
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.
Interventions
OTHERlifestyle modification
nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization
Sponsors
Holy Cross Hospital, Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Metabolic syndrome patients meeting 3 of 5 criteria: 1. waist circumference (37 in) in white and AA men, (35 in) in Asian men, and (31.5 in) in women; 2. triglycerides ≥150 mg/dl; 3. high-density lipoprotein cholesterol (HDL-C) \<40 mg/dl in men and \<50 mg/dl in women; 4. blood pressure ≥130/85 mm Hg 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reversal of metabolic syndrome | At the end of 12 months | Change in number of metabolic syndrome risk factors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | within three to five years of intervention | KM curve of patients with change in metabolic risk factors vs those with no change |
| hemoglobin A1c | At the end of 12 months | change in hemoglobin A1c (percentage) |
| waist circumference | At the end of 12 months | change in waist circumference (inches) |
| blood pressure | At the end of 12 months | change in average blood pressure (mmHg) |
| total cholesterol | At the end of 12 months | change in total cholesterol (mg/dL) |
Countries
United States
Contacts
Primary ContactCharles Russo, MD
Backup ContactAbdullah Sarkar, MD
Outcome results
None listed