Cardiometabolic SyndromePICMANNCT06062836
The Platform for Interdisciplinary Cardiovascular-metabolic-neurovascular Diseases (PICMAN)
An observational study of Cardiometabolic Syndrome, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Background Changes in metabolism and mitochondrial function appear to precede cardiac dysfunction, with much evidence supporting metabolic dysregulation as one of the earliest precursors of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Syndrome
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2022to Apr 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants between the ages of 21 and 70 at screening without a prior history of MACE, coronary artery disease diagnosis, established diabetes, with a calculated 10-year ASCVD risk > 5% based on QRISK3 calculator are eligible for PICMAN. Recruitment of individuals takes place at NUHS, where community-dwelling individuals without cardiac disease will be referred via outreach to primary care and community partners in Singapore.
Who may be able to join
- Patients aged 21-70 at screening
- 10-year ASCVD risk > 5% measured by QRISK 3 calculator
Who cannot join
- Established DM (Prior diagnosis, long term medications or HbA1c >=6.5)
- Established CVD, such as ischemic heart disease, cerebrovascular accident, heart failure, atrial fibrillation
- Pregnancy
- Known contraindications to CT scan, such as allergy to contrast
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Health System
Singapore
Sankari Ramanathan
About this study
Official title: The Platform for Interdisciplinary Cardiovascular-metabolic-neurovascular Diseases (PICMAN) Across National University Health System (NUHS)
Background Changes in metabolism and mitochondrial function appear to precede cardiac dysfunction, with much evidence supporting metabolic dysregulation as one of the earliest precursors of cardiovascular disease. We hypothesise that quantifiable metabolic inflexibility may be representative of an individual in his/her silent, but high-risk progression towards insulin resistance, diabetes and cardiovascular disease. The platform for interdisciplinary cardiovascular-metabolic-neurovascular diseases (PICMAN) across National University Health System (NUHS) is a pilot, prospective, multi-ethnic cohort study in Singapore.
Through extensive phenotyping in a preventive cardiology cohort, the central aim is to define the metabolic flexibility range in a cohort of individuals at elevated risk of atherosclerotic cardiovascular disease, to correlate metabolic flexibility to measures of cardiometabolic health, including diastolic dysfunction, coronary and cerebral atherosclerosis, body fat distribution and severity of non-alcoholic fatty liver disease.
Read the detailed description
Aims
- Define norms for metabolic flexibility in a multi-ethnic Southeast Asian cohort of individuals without manifest ASCVD
- Understand the association of metabolic inflexibility with cardiovascular measures of diastolic dysfunction and coronary and cerebral atherosclerosis
- Understand the association of metabolic inflexibility with measures of body fat distribution
- Understand the correlation between metabolic flexibility and insulin sensitivity along the spectrum of subclinical cardiovascular disease and severity of non-alcoholic fatty liver disease
- Associations of the gut microbiome as well as metabolomic and molecular markers with cardio-cerebrovascular measures, metabolic flexibility and liver fibrosis
The PICMAN study seeks to lay the foundations for further future larger scale and more experimentally ambitious studies based on the overarching hypothesis that metabolic flexibility is an early marker in subclinical cardiovascular disease, indicating a point of timely intervention where the disease process is still reversible. The importance of a deeply-phenotyped local cohort will allow us to study the progression of CVD in seemingly well adults, converging imaging, biochemical, metabolic markers, and 'omics analysis.
- Conditions
- Cardiometabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic flexibility
Metabolic flexibility will be calculated (deltaRQ)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Apr 2022
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic SyndromeStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mayank Dalakoti, Principal investigator, National University Health SystemRoger Foo, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062836
- Sponsor's protocol ID
- PICMAN
- Acronym
- PICMAN
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Platform for Interdisciplinary Cardiovascular-metabolic-neurovascular Diseases (PICMAN) Across National University Health System (NUHS)
- ClinicalTrials.gov ID
- NCT06062836
- Acronym / sponsor ID
- PICMAN / PICMAN
- Conditions
- Cardiometabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 2 Oct 2023 (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.
Background Changes in metabolism and mitochondrial function appear to precede cardiac dysfunction, with much evidence supporting metabolic dysregulation as one of the earliest precursors of cardiovascular disease. We hypothesise that quantifiable metabolic inflexibility may be representative of an individual in his/her silent, but high-risk progression towards insulin resistance, diabetes and cardiovascular disease. The platform for interdisciplinary cardiovascular-metabolic-neurovascular diseases (PICMAN) across National University Health System (NUHS) is a pilot, prospective, multi-ethnic cohort study in Singapore.
Through extensive phenotyping in a preventive cardiology cohort, the central aim is to define the metabolic flexibility range in a cohort of individuals at elevated risk of atherosclerotic cardiovascular disease, to correlate metabolic flexibility to measures of cardiometabolic health, including diastolic dysfunction, coronary and cerebral atherosclerosis, body fat distribution and severity of non-alcoholic fatty liver disease.
Detailed description
Aims
- Define norms for metabolic flexibility in a multi-ethnic Southeast Asian cohort of individuals without manifest ASCVD
- Understand the association of metabolic inflexibility with cardiovascular measures of diastolic dysfunction and coronary and cerebral atherosclerosis
- Understand the association of metabolic inflexibility with measures of body fat distribution
- Understand the correlation between metabolic flexibility and insulin sensitivity along the spectrum of subclinical cardiovascular disease and severity of non-alcoholic fatty liver disease
- Associations of the gut microbiome as well as metabolomic and molecular markers with cardio-cerebrovascular measures, metabolic flexibility and liver fibrosis
The PICMAN study seeks to lay the foundations for further future larger scale and more experimentally ambitious studies based on the overarching hypothesis that metabolic flexibility is an early marker in subclinical cardiovascular disease, indicating a point of timely intervention where the disease process is still reversible. The importance of a deeply-phenotyped local cohort will allow us to study the progression of CVD in seemingly well adults, converging imaging, biochemical, metabolic markers, and 'omics analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants between the ages of 21 and 70 at screening without a prior history of MACE, coronary artery disease diagnosis, established diabetes, with a calculated 10-year ASCVD risk > 5% based on QRISK3 calculator are eligible for PICMAN. Recruitment of individuals takes place at NUHS, where community-dwelling individuals without cardiac disease will be referred via outreach to primary care and community partners in Singapore.
Key inclusion criteria (2 listed)
- Patients aged 21-70 at screening
- 10-year ASCVD risk > 5% measured by QRISK 3 calculator
Key exclusion criteria (4 listed)
- Established DM (Prior diagnosis, long term medications or HbA1c >=6.5)
- Established CVD, such as ischemic heart disease, cerebrovascular accident, heart failure, atrial fibrillation
- Pregnancy
- Known contraindications to CT scan, such as allergy to contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic flexibility
Time frame: Up to 5 years
Metabolic flexibility will be calculated (deltaRQ)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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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.
Mayank Dalakoti principal investigator
National University Health System
Roger Foo principal investigator
National University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiometabolic Syndrome, run by National University Hospital, Singapore at 1 site in Singapore.
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 2 inclusion and 4 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 2 Oct 2023. 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 Singapore. 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 Mayank Dalakoti (+6566011036, mayank_dalakoti@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic flexibility (time frame: Up to 5 years). 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 2 Oct 2023.