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NCT05256706Completed

SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes

Evaluating the Impact of SomaSignal Tests on Medical Management and Change in Risk in Patients With Type 2 Diabetes at Higher Risk of Cardiovascular Disease

Source: ClinicalTrials.gov · Last updated 9 Jan 2025

Brief summary (registry, in English)

Despite the development of novel treatments, cardiovascular disease (CVD) remains the leading cause of death and disability. It has been observed in clinical practice, that the use of novel glycemia-lowering therapies with cardioprotective features remains profoundly low despite proven efficacy. It has been proposed that such low uptake is more related to insurance type and coverage than to risk assessment. While it can be easy to blame prescribing deficiencies on complacent physicians and/or over-frugal payors, SomaLogic believes there is more likely to be a fundamental problem with the cost and risk-effective allocation of such therapies, which are neither low in cost nor free of adverse events. As current clinical trials and guidelines tend to "bundle" participants together, there is an absence of individualized assessment of residual cardiovascular risk. This leads to physicians, participants, and payors being relatively uninformed as to the need for and/or likely benefits of such therapies in an individual. Simply giving every eligible participant a drug regardless of residual risk would be unaffordable and would create adverse effects and costs for people at low residual risk who might not actually benefit from the drugs. To resolve this lack of precision in risk assessment, SomaLogic has performed the largest ever proteomic program to date with over 36,000 samples from 26,000 participants in eleven clinical studies, for a total of over 180,000,000 protein measurements, to develop and validate a surrogate proteomic endpoint for cardiovascular outcomes. The SomaSignal Cardiovascular Risk (SSCVR) test, a 27-protein model encompassing ten biological systems.

Status (registry)
Completed
Study type
Interventional
Enrollment
143 (actual)
First submitted
20 Jan 2022
Start date
Feb 2022
Primary completion date
Dec 2023
Lead sponsor
Emory University
NCT number
NCT05256706

What you commit to

  • Study type: Interventional
  • Participants enrolled: 143
  • From Feb 2022 to the primary completion date, Dec 2023
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • Systemic Lupus Erythematous (SLE)
  • Pregnancy
  • Intolerance or contraindication for use of GLP-1 RA, SGLT2i, and PCSK9i
  • Inability to understand English (currently, SomaSignal testing information, guides, educational materials, and reports are only available in English.)

Who the study is looking for

  • Male and female participants 40 years and older
  • Diagnosis of type 2 diabetes (T2D) \[according to American Diabetes Association (ADA) guidelines\]
  • Able to provide consent
  • Eligible for (per drug label/guidelines) at least one of the following drug classes: sodium-glucose cotransporter 2 inhibitors (SGLT2i), proprotein convertase subtilisin/kexin type 9 (PCSK9i), glucagon-like peptide receptor agonists (GLP-1 RA) but not currently prescribed any of these classes of drugs, or only prescribed PCSK9i

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Grady Health System
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Emory Hospital Midtown
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Emory Saint Joseph's Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Emory Clinic, Emory University Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.