Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes

Not Applicable

• Conditions: Metabolic Syndrome; Lifestyle Risk Reduction; ASCVD
• Interventions: Other: lifestyle modification

• Registration Number: NCT04093440
• Lead Sponsor: Holy Cross Hospital, Florida

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-16
• Last Update Submitted: 2019-09-16
• Study First Posted: 2019-09-18
• Last Update Posted: 2019-09-18
• Study Start: 2019-10
• Primary Completion: 2020-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observation	lifestyle modification	lifestyle modification: nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization

Primary Outcome Measures

Name	Time	Method
Reversal of metabolic syndrome	At the end of 12 months	Change in number of metabolic syndrome risk factors

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Internal Medicine Residency Clinic at Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States