An Observational Study of Patients With Metabolic Syndrome and Related Conditions
1 other identifier
observational
2,000,000
0 countries
N/A
Brief Summary
TARGET-METABOLIC is an observational research study to conduct a comprehensive review of outcomes for patients with metabolic syndrome and related conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
May 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2038
May 6, 2023
April 1, 2023
15.6 years
March 9, 2023
April 24, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
15 Years
Secondary Outcomes (3)
To evaluate provider management practices in the treatment of patients with metabolic syndrome and related conditions
15 Years
To evaluate longitudinal and patient reported outcomes in patients with metabolic syndrome and related conditions
15 Years
To select and evaluate quality of care measures for patients with metabolic syndrome and related conditions
15 Years
Study Arms (2)
Disease Cohort
Observational
Engaged Cohort
Observational
Eligibility Criteria
The study will include adults with metabolic syndrome and related conditions.
You may qualify if:
- \- 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
You may not qualify if:
- Death
- Manual removal (sponsor or site request)
- No EHR interface encounter \> 3 years
- Engaged Cohort
- Adult patients diagnosed and managed for these conditions invited to participate
- Ability to provide written informed consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Whole blood with serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2023
First Posted
May 6, 2023
Study Start
May 24, 2023
Primary Completion (Estimated)
December 31, 2038
Study Completion (Estimated)
December 31, 2038
Last Updated
May 6, 2023
Record last verified: 2023-04