An Observational Study of Patients With… | Clinical Trial

Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

To evaluate provider management practices in the treatment of patients with metabolic syndrome and related conditions

Time frame: 15 Years

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.
To evaluate longitudinal and patient reported outcomes in patients with metabolic syndrome and related conditions

Time frame: 15 Years

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.
To select and evaluate quality of care measures for patients with metabolic syndrome and related conditions

Time frame: 15 Years
- Identify deficiencies and select best practices in care of patients
- Develop a technology infrastructure to evaluate quality measures to support clinicians.

Sponsors and collaborators

Lead sponsor

Target PharmaSolutions, Inc.

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2038
Study completion: 2038
First posted: May 6, 2023
Registry last updated: May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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