Metabolic SyndromeNCT05842811
An Observational Study of Patients With Metabolic Syndrome and Related Conditions
An observational study of Metabolic Syndrome, run by Target PharmaSolutions, Inc..
Trial summary
TARGET-METABOLIC is an observational research study to conduct a comprehensive review of outcomes for patients with metabolic syndrome and related conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 2,000,000 participants
- Where
- No sites listed yet
- Study dates
- 24 May 2023to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adults with metabolic syndrome and related conditions.
Who may be able to join
- Adult patients at the time of enrollment with a diagnosis of metabolic syndrome or related conditions by ICD-10 code or with clinically calculated BMI ≥ 30 in the EHR/health system interface
- Adult patients diagnosed and managed for these conditions invited to participate
- Ability to provide written informed consent
Who cannot join
- Death
- Manual removal (sponsor or site request)
- No EHR interface encounter > 3 years
- Engaged Cohort
- Patient expressed desire to withdraw consent to complete PROs
- Failure to complete PROs within 24 weeks of initial invitation
- Greater than 24 months lapse of survey completion after baseline surveys completed
- Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort
About this study
TARGET-METABOLIC is an observational research study to conduct a comprehensive review of outcomes for patients with metabolic syndrome and related conditions.
- Conditions
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Disease Cohort | Observational | |
| Engaged Cohort | Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the natural history of disease in patients with metabolic syndrome and related conditions
A detailed analysis of available demographics, anthropometric characteristics, glycemic metrics, medications, co-morbidities, and medical history from sites across the US will inform the profile for various patient populations enrolled into the study. Collection of detailed medical records will be curated and analyzed to characterize disease natural history, clinical course of disease, number and types of interventions, current treatment paradigms, and the patient diagnostic journey. These data may also establish incidence rates of events of special interest. Collection of prospective medical records for each patient enables the continuation of these analyses longitudinally for changes and progression to characterize the clinical course of disease. The progression of pre-existing co-morbidities and variances across populations will also be evaluated.
Measured: 15 Years
To assess safety and effectiveness of treatments for metabolic syndrome and related conditions.
The study will evaluate the characteristics of patients receiving various treatments, effectiveness of treatment, and medical events that develop while receiving treatment for metabolic syndrome and related conditions. Treatments may be pharmacologic, surgical, procedures, radiologic or other interventions given to change the disease course/outcomes. Interval disease and medical events may vary depending on the patient's stage and type of disease and extent of co-morbidities at study entry and time of diagnosis.
Measured: 15 Years
Secondary outcomes (3)
To evaluate provider management practices in the treatment of patients with metabolic syndrome and related conditions
Health care provider type, clinic setting, reason for initiating/not initiating/adjusting dosing of treatments or interventions (i.e., surgery, radiation), reason for discontinuing/switching treatments, and monitoring outcomes on and off treatment, will be captured as available in the provided EHR and/or through linked data. Disease-specific quality measures will be selected and evaluated, and the curated data can enable analyses to describe and evaluate healthcare utilization patterns.
Measured: 15 Years
To evaluate longitudinal and patient reported outcomes in patients with metabolic syndrome and related conditions
Longitudinal clinical outcomes and disease progression will be assessed. Self-reported patient health measures collect information directly from patients to measure physical, mental, and social health. These measures can help clinicians better understand how the disease state and/or various treatments affect what patients are able to do and the symptoms they experience beyond what is typically derived and reported in the EHR as part of traditional clinical evaluations. The information can also be used to help patients make informed decisions about their healthcare and treatment options.
Measured: 15 Years
To select and evaluate quality of care measures for patients with metabolic syndrome and related conditions
- Identify deficiencies and select best practices in care of patients
- Develop a technology infrastructure to evaluate quality measures to support clinicians.
Measured: 15 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start24 May 2023 (estimated)
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2038 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Target PharmaSolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842811
- Sponsor's protocol ID
- TARGET-METABOLIC
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Patients With Metabolic Syndrome and Related Conditions
- ClinicalTrials.gov ID
- NCT05842811
- Acronym / sponsor ID
- TARGET-METABOLIC
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000,000 participants (estimated)
- Lead sponsor
- Target PharmaSolutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2023 (estimated)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 6 May 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.
TARGET-METABOLIC is an observational research study to conduct a comprehensive review of outcomes for patients with metabolic syndrome and related conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease Cohort | – | –Observational |
| Engaged Cohort | – | –Observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adults with metabolic syndrome and related conditions.
Key inclusion criteria (3 listed)
- Adult patients at the time of enrollment with a diagnosis of metabolic syndrome or related conditions by ICD-10 code or with clinically calculated BMI ≥ 30 in the EHR/health system interface
- Adult patients diagnosed and managed for these conditions invited to participate
- Ability to provide written informed consent
Key exclusion criteria (8 listed)
- Death
- Manual removal (sponsor or site request)
- No EHR interface encounter > 3 years
- Engaged Cohort
- Patient expressed desire to withdraw consent to complete PROs
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
To characterize the natural history of disease in patients with metabolic syndrome and related conditions
Time frame: 15 Years
A detailed analysis of available demographics, anthropometric characteristics, glycemic metrics, medications, co-morbidities, and medical history from sites across the US will inform the profile for various patient populations enrolled into the study. Collection of detailed medical records will be curated and analyzed to characterize disease natural history, clinical course of disease, number and types of interventions, current treatment paradigms, and the patient diagnostic journey. These data may also establish incidence rates of events of special interest. Collection of prospective medical records for each patient enables the continuation of these analyses longitudinally for changes and progression to characterize the clinical course of disease. The progression of pre-existing co-morbidities and variances across populations will also be evaluated.
To assess safety and effectiveness of treatments for metabolic syndrome and related conditions.
Time frame: 15 Years
The study will evaluate the characteristics of patients receiving various treatments, effectiveness of treatment, and medical events that develop while receiving treatment for metabolic syndrome and related conditions. Treatments may be pharmacologic, surgical, procedures, radiologic or other interventions given to change the disease course/outcomes. Interval disease and medical events may vary depending on the patient's stage and type of disease and extent of co-morbidities at study entry and time of diagnosis.
3 secondary outcomes
To evaluate provider management practices in the treatment of patients with metabolic syndrome and related conditions
Time frame: 15 Years
To evaluate longitudinal and patient reported outcomes in patients with metabolic syndrome and related conditions
Time frame: 15 Years
To select and evaluate quality of care measures for patients with metabolic syndrome and related conditions
Time frame: 15 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Target PharmaSolutions, Inc..
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the natural history of disease in patients with metabolic syndrome and related conditions (time frame: 15 Years). The study lists 2 primary outcomes in all. 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 6 May 2023.