Metabolic SyndromeCOSMETICNCT04093440
Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes
A study testing lifestyle modification in people with Metabolic Syndrome and ASCVD, run by Holy Cross Hospital, Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Syndrome, ASCVD, Lifestyle Risk Reduction
- What is being tested?
- lifestyle modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with less than 5 year survival
- Patients with cancer undergoing therapy or on palliative treatment
- Patients with end stage heart failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Internal Medicine Residency Clinic at Holy Cross Hospital
Fort Lauderdale, Florida, 33334
Charles Russo, MD, 954-491-2160
About this study
Official title: CardiOmetabolic SyndroME Response to Therapeutic lIfestyle Changes
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.
- Conditions
- Metabolic Syndrome, ASCVD, Lifestyle Risk Reduction
- Being tested
- lifestyle modification
- Keywords
- cardiometabolic clinic
- Medical subject headings
- Metabolic Syndrome, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle modificationOther
nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization
| Study group | Role | What they receive |
|---|---|---|
| Observation | Other | lifestyle modification: nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization Receives: Other: lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of metabolic syndrome
Change in number of metabolic syndrome risk factors
Measured: At the end of 12 months
Secondary outcomes (5)
Mortality
KM curve of patients with change in metabolic risk factors vs those with no change
Measured: within three to five years of intervention
hemoglobin A1c
change in hemoglobin A1c (percentage)
Measured: At the end of 12 months
waist circumference
change in waist circumference (inches)
Measured: At the end of 12 months
blood pressure
change in average blood pressure (mmHg)
Measured: At the end of 12 months
total cholesterol
change in total cholesterol (mg/dL)
Measured: At the end of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holy Cross Hospital, Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Russo, MD, Principal investigator, Jim Moran Heart and Vascular Research Center at Holy Cross HospitalPaul Papagni, JD, Study director, Jim Moran Heart and Vascular Research Center at Holy Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093440
- Sponsor's protocol ID
- HCV-19-001
- Acronym
- COSMETIC
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardiOmetabolic SyndroME Response to Therapeutic lIfestyle Changes
- ClinicalTrials.gov ID
- NCT04093440
- Acronym / sponsor ID
- COSMETIC / HCV-19-001
- Conditions
- Metabolic Syndrome, ASCVD, Lifestyle Risk Reduction
- Keywords
- cardiometabolic clinic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Holy Cross Hospital, FloridaUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | Other | Other: lifestyle modificationlifestyle modification: nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Metabolic syndrome patients meeting 3 of 5 criteria:
- Patients requiring secondary ASCD prevention
Key exclusion criteria (3 listed)
- Patients with less than 5 year survival
- Patients with cancer undergoing therapy or on palliative treatment
- Patients with end stage heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle modificationnutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization | Other | Observation |
Primary outcome
Reversal of metabolic syndrome
Time frame: At the end of 12 months
Change in number of metabolic syndrome risk factors
5 secondary outcomes
Mortality
Time frame: within three to five years of intervention
hemoglobin A1c
Time frame: At the end of 12 months
waist circumference
Time frame: At the end of 12 months
blood pressure
Time frame: At the end of 12 months
total cholesterol
Time frame: At the end of 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Russo, MD principal investigator
Jim Moran Heart and Vascular Research Center at Holy Cross Hospital
Paul Papagni, JD study director
Jim Moran Heart and Vascular Research Center at Holy Cross Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle modification in people with Metabolic Syndrome and ASCVD, run by Holy Cross Hospital, Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Russo, MD (9547718000, chuckiedrusso@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal of metabolic syndrome (time frame: At the end of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.