COSMETIC: Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Reversal of metabolic syndrome [At the end of 12 months]
Change in number of metabolic syndrome risk factors
Secondary Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Metabolic syndrome patients meeting 3 of 5 criteria:
-
waist circumference (37 in) in white and AA men, (35 in) in Asian men, and (31.5 in) in women;
-
triglycerides ≥150 mg/dl;
-
high-density lipoprotein cholesterol (HDL-C) <40 mg/dl in men and <50 mg/dl in women;
-
blood pressure ≥130/85 mm Hg
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Internal Medicine Residency Clinic at Holy Cross Hospital | Fort Lauderdale | Florida | United States | 33334 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCV-19-001