Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes (COSMETIC)

CardiOmetabolic SyndroME Response to Therapeutic lIfestyle Changes

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 Overview

• Status: Unknown
• Conditions: Metabolic Syndrome; Lifestyle Risk Reduction; ASCVD
• Intervention / Treatment: Other: lifestyle modification

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33334
      • Internal Medicine Residency Clinic at Holy Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Observation; lifestyle modification: nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization	Other: lifestyle modification; nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Holy Cross Hospital, Florida
• Investigators: Principal Investigator: Charles Russo, MD, Jim Moran Heart and Vascular Research Center at Holy Cross Hospital; Study Director: Paul Papagni, JD, Jim Moran Heart and Vascular Research Center at Holy Cross Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: cardiometabolic clinic
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: HCV-19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No