Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes (COSMETIC)

Holy Cross Hospital, Florida

Status: Unknown

Conditions: Lifestyle Risk Reduction; ASCVD; Metabolic Syndrome

Treatments: Other: lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT04093440

HCV-19-001

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Observation

Other group

Description:

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

Treatment:

Other: lifestyle modification