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Not yet recruiting NCT05842811

An Observational Study of Patients With Metabolic Syndrome and Related Conditions

— Observational Metabolic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Metabolic Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

TARGET-METABOLIC is an observational research study to conduct a comprehensive review of outcomes for patients with metabolic syndrome and related conditions.

Primary outcome measures

  • To characterize the natural history of disease in patients with metabolic syndrome and related conditions [Time frame: 15 Years]
  • To assess safety and effectiveness of treatments for metabolic syndrome and related conditions. [Time frame: 15 Years]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Disease Cohort

Inclusion criteria

\- 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

Exclusion criteria

  • Death
  • Manual removal (sponsor or site request)
  • No EHR interface encounter > 3 years

Engaged Cohort

Inclusion criteria

  • Adult patients diagnosed and managed for these conditions invited to participate
  • Ability to provide written informed consent

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05842811 · TARGET-METABOLIC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗