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Proteomic Risk Stratification

CVD-T2D Informed Medical Management (Informed) for Type 2 Diabetes (PORTRAIT-DM Trial)

N/A

Waitlist Available

Led By Ian Neeland, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

PORTRAIT-DM Trial Summary

This trial is testing whether a new way of managing medical care, called SomaSignal Informed Medical Management, is better than the current standard of care.

Eligible Conditions

Type 2 Diabetes

PORTRAIT-DM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The relation of prescription rates of cardioprotective medications (SGLT2i or GLP1 RA) to CVD-T2D test risk assessment in the Informed group vs. Uninformed group.

Secondary outcome measures

Survey of healthcare providers on the impact of SomaLogic's CVD-T2D calculator on patient care, medication prescription, and risk perception.

Other outcome measures

Cost effectiveness of the SomaLogic CVD-T2D test in the Informed vs. Uninformed groups.

The change in prescription rates of cardioprotective medications (SGLT2i or GLP1 RA) after revealing the CVD-T2D and Metabolic Factors test results at the end of the study in the Uninformed group.

The change in prescription rates of cardioprotective medications (SGLT2i or GLP1 RA) after revealing the Metabolic Factors test results at the end of the study in the Informed group.

PORTRAIT-DM Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of Care (Uninformed)Experimental Treatment1 Intervention

The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) and Metabolic Factors test results will be provided in the Open Label Extension; results will not be provided to provider and participant until study conclusion.

Group II: CVD-T2D Informed Medical Management (Informed)Experimental Treatment1 Intervention

The SomaSignal Metabolic Factors test results will be provided in the Open Label Extension; results will not be provided to provider and participant until study conclusion.

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Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor

317 Previous Clinical Trials

340,107 Total Patients Enrolled

SomaLogic, Inc.Industry Sponsor

6 Previous Clinical Trials

1,188 Total Patients Enrolled

Ian Neeland, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

3 Previous Clinical Trials

316 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research trial take into consideration seniors over the age of 70?

"Patients aged between 40 and 89 years old are currently eligible for admission into this medical trial."

Answered by AI

How many individuals are being recruited to participate in this clinical trial?

"Affirmative, the clinical trial is still open to recruitment. This research project was initially posted on January 26th 2022 and modified for the last time on April 7th 2022; 600 patients are needed at a single medical centre."

Answered by AI

Are there any remaining vacancies in this clinical investigation?

"According to clincaltrials.gov, this clinical trial is actively searching for participants that meet the eligibility criteria. It was first published on January 26th 2022 and last updated on April 7th 2022."

Answered by AI

Who is eligible to be a part of this research trial?

"This trial is searching for 600 participants with type 2 diabetes mellitus between the ages of 40 and 89. Consequently, those seeking to become part of this study must meet these criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus

Ian J. Neeland, MD 2022. "Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05182359.