Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes

Holy Cross Hospital, Florida250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

250

Conditions

Metabolic Syndrome ASCVD Lifestyle Risk Reduction

Interventions

lifestyle modificationOTHER

nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Internal Medicine Residency Clinic at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Outcomes

Primary Outcomes

Reversal of metabolic syndrome

Change in number of metabolic syndrome risk factors

Time frame: At the end of 12 months

Secondary Outcomes

Mortality

KM curve of patients with change in metabolic risk factors vs those with no change

Time frame: within three to five years of intervention

hemoglobin A1c

change in hemoglobin A1c (percentage)

Time frame: At the end of 12 months

waist circumference

change in waist circumference (inches)

Time frame: At the end of 12 months

blood pressure

change in average blood pressure (mmHg)

Time frame: At the end of 12 months

total cholesterol

change in total cholesterol (mg/dL)

Time frame: At the end of 12 months

Central Contacts

Charles Russo, MD

CONTACT

9547718000 chuckiedrusso@aol.com

Abdullah Sarkar, MD

CONTACT

4698183688 axs2500@miami.edu

Data from ClinicalTrials.gov

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