Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes

Metabolic Syndrome Clinical Trial

— COSMETIC  

Official title:

CardiOmetabolic SyndroME Response to Therapeutic lIfestyle Changes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04093440
• Other study ID #: HCV-19-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2019
• Est. completion date: December 2021

Study information

• Verified date: September 2019
• Source: Holy Cross Hospital, Florida
• Contact: Charles Russo, MD
• Phone: 9547718000
• Email: chuckiedrusso[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• ASCVD
• Lifestyle Risk Reduction
• Metabolic Syndrome
• Syndrome

Intervention

Other:
• lifestyle modification
nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization

Locations

Country	Name	City	State
United States	Internal Medicine Residency Clinic at Holy Cross Hospital	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Holy Cross Hospital, Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal of metabolic syndrome	Change in number of metabolic syndrome risk factors	At the end of 12 months
Secondary	Mortality	KM curve of patients with change in metabolic risk factors vs those with no change	within three to five years of intervention
Secondary	hemoglobin A1c	change in hemoglobin A1c (percentage)	At the end of 12 months
Secondary	waist circumference	change in waist circumference (inches)	At the end of 12 months
Secondary	blood pressure	change in average blood pressure (mmHg)	At the end of 12 months
Secondary	total cholesterol	change in total cholesterol (mg/dL)	At the end of 12 months