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Completed

NCT Number: NCT05166382

Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications

The purpose of this study is to learn more about using a proteomic test called the SomaSignal Cardiovascular (CV) Risk Test in Type 2 Diabetes (CVD-T2D) to improve medical care for patients.

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Key information

Conditions

Type 2 Diabetes Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aanchal Gupta

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Provider

  • Licensed provider actively practicing medicine at a UC Health clinic that routinely provides medical treatment for patients with type 2 diabetes

Inclusion criteria

Patient

  • Patients receiving care at a UC Health system
  • Age 40 years or older
  • Type 2 Diabetes
  • Eligible for (per drug label/guidelines) at least one of the following classes: SGLT2i, PCSK9i, GLP-1 RA
  • Able to provide consent

Exclusion criteria

  • Use of SGLT2i , GLP1RA and PCSK9i within the 3 months prior to enrollment
  • Systemic Lupus Erythematous (SLE)*
  • Pregnancy (as determined by self report)
  • Intolerance or contraindication for use of both GLP1RA and SGLT2i
  • History of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening
  • Samples provided by patients with SLE may fail to produce results or may produce inaccurate results because autoantibodies in the patient plasma may interact with the DNA-based reagents used in the assay

Treatment and study plan

Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)

Behavioral

Providers and patients will be informed of CVD-T2D test results that predict the risk of cardiovascular events over the next 4 years after their first research visit.

Other names: Informed

Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)

Behavioral

Providers and patients will be informed of CVD-T2D test results that predict the risk of cardiovascular events over the next 4 years after their second research visit.

Other names: Uninformed

Primary outcomes

  1. Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline

    Time frame: Baseline

    Determine whether risk stratification results from SomaLogic's CVDT2D test leads to risk concordant changes in prescriptions and/or medical management through a patient and provider completed questionnaire. Questionnaire is a binary measurement of "prescribed medicine?" with possible answers "Yes" or "No". Number of participants prescribed medication will be reported.

  2. Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6

    Time frame: 6 months

    Determine whether risk stratification results from SomaLogic's CVDT2D test leads to risk concordant changes in prescriptions and/or medical management through a patient and provider completed questionnaire. Questionnaire is a binary measurement of "prescribed medicine?" with possible answers "Yes" or "No". Number of participants prescribed medication will be reported.

Secondary outcomes

  1. Change in protein predicted risk: SomaLogic CVDT2D test

    Time frame: Baseline, 6 months

    Longitudinal changes in protein-predicted risk as measured by SomaLogic CVDT2D test over 6 months

  2. Change in protein predicted risk: biomarkers

    Time frame: Baseline, 6 months

    Longitudinal changes in protein-predicted risk as measured by conventional biomarkers of risk over 6 months

  3. Standard of care risk assessment: body mass index (BMI) at baseline

    Time frame: Baseline

    Body mass index (BMI) measures a person's weight in kilograms divided by the square of the person's height in meters. Scores between 18.5 and 24.9 indicate a healthy weight.

  4. Standard of care risk assessment: body mass index (BMI) at 6 months

    Time frame: 6 months

    Body mass index (BMI) measures a person's weight in kilograms divided by the square of the person's height in meters. Scores between 18.5 and 24.9 indicate a healthy weight.

  5. Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline

    Time frame: Baseline

    The Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) measures the estimated risk of cardiovascular disease over the next ten years. Possible scores range from <5% to >/=20%, with higher scores indicating a worse outcome.

  6. Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months

    Time frame: 6 months

    The Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) measures the estimated risk of cardiovascular disease over the next ten years. Possible scores range from <5% to >/=20%, with higher scores indicating a worse outcome.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • SomaLogic, Inc.

Registry information

Official study title

Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications: An Adaptive Implementation Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2021
Registry last updated
Mar 20, 2025

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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