Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes (COSMETIC)
Primary Purpose
Metabolic Syndrome, ASCVD, Lifestyle Risk Reduction
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lifestyle modification
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring cardiometabolic clinic
Eligibility 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
Sites / Locations
- Internal Medicine Residency Clinic at Holy Cross Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Observation
Arm Description
lifestyle modification: nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization
Outcomes
Primary Outcome Measures
Reversal of metabolic syndrome
Change in number of metabolic syndrome risk factors
Secondary Outcome Measures
Mortality
KM curve of patients with change in metabolic risk factors vs those with no change
hemoglobin A1c
change in hemoglobin A1c (percentage)
waist circumference
change in waist circumference (inches)
blood pressure
change in average blood pressure (mmHg)
total cholesterol
change in total cholesterol (mg/dL)
Full Information
NCT ID
NCT04093440
First Posted
September 5, 2019
Last Updated
September 16, 2019
Sponsor
Holy Cross Hospital, Florida
1. Study Identification
Unique Protocol Identification Number
NCT04093440
Brief Title
Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes
Acronym
COSMETIC
Official Title
CardiOmetabolic SyndroME Response to Therapeutic lIfestyle Changes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holy Cross Hospital, Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, ASCVD, Lifestyle Risk Reduction
Keywords
cardiometabolic clinic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Observation
Arm Type
Other
Arm Description
lifestyle modification: nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization
Intervention Type
Other
Intervention Name(s)
lifestyle modification
Intervention Description
nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization
Primary Outcome Measure Information:
Title
Reversal of metabolic syndrome
Description
Change in number of metabolic syndrome risk factors
Time Frame
At the end of 12 months
Secondary Outcome Measure Information:
Title
Mortality
Description
KM curve of patients with change in metabolic risk factors vs those with no change
Time Frame
within three to five years of intervention
Title
hemoglobin A1c
Description
change in hemoglobin A1c (percentage)
Time Frame
At the end of 12 months
Title
waist circumference
Description
change in waist circumference (inches)
Time Frame
At the end of 12 months
Title
blood pressure
Description
change in average blood pressure (mmHg)
Time Frame
At the end of 12 months
Title
total cholesterol
Description
change in total cholesterol (mg/dL)
Time Frame
At the end of 12 months
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Russo, MD
Phone
9547718000
Email
chuckiedrusso@aol.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah Sarkar, MD
Phone
4698183688
Email
axs2500@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Russo, MD
Organizational Affiliation
Jim Moran Heart and Vascular Research Center at Holy Cross Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Papagni, JD
Organizational Affiliation
Jim Moran Heart and Vascular Research Center at Holy Cross Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Internal Medicine Residency Clinic at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Russo, MD
Phone
954-491-2160
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes
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