Clinical trial NCT05256706: SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: cardiovascular risk
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: SomaLogic, Inc.
First posted: 2022-02-25
Enrollment: 143
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: This study is being done to evaluate the use of a new test for the management and treatment of patients who are at high risk of heart disease. The test, called a "SomaSignal Test", makes use of personalized proteomics. "Proteomes" refer to a set of proteins produced in the body. Proteins can affect the function of our bodies and can regulate disease, behavior, and drug treatments. The research team's hypothesis is that the SomaSignal Test can study these proteins and provide results that can help in the management of heart disease.

Potential benefits include increased participant engagement and satisfaction from increased personalized medical knowledge and improved participant outcomes through personalized risk stratification, more precise clinical care, and improvements in the triage of medical interventions and education. There may be improved health outcomes in the subset of participants who have a residual risk based on the SomaSignal Test test that they were previously unaware of, and who may receive treatment with a drug or additional lifestyle intervention they were previously eligible for but were not undertaking at the start of the study.

All participating providers will be provided education and training on SomaSignal testing including how to interpret and educate participants on the results. There will be two study visits. Participants will be randomized into one of 2 arms. Blood samples and information collected for this study will be shared with SomaLogic Inc., the company where sample testing and analysis will be done.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results
timeFrame: 6 months and 12 months after baseline
Secondary outcomes:
measure: Number of Participants With Changes in the SSCVD Results
timeFrame: Baseline and 6 months
measure: Changes in Low-density Lipoprotein (LDL)
timeFrame: 6 months and 12 months
measure: Changes in High-density Lipoprotein (HDL)
timeFrame: 6 months and 12 months
measure: Changes in Triglycerides (TG) Levels
timeFrame: 6 months and 12 months
measure: Changes in Glucose Levels
timeFrame: 6 months and 12 months
measure: Changes in Glycated Hemoglobin Test (HbA1C)
timeFrame: 6 months and 12 months
measure: Changes in Weight
timeFrame: 6 months and 12 months
measure: Changes in Body Mass Index (BMI)
timeFrame: 6 months and 12 months
measure: Number of Participants Who Experienced Changes in Tobacco Exposure
timeFrame: 6 months and 12 months
measure: Number of Participants Who Experienced a Change in Physical Activity
timeFrame: 6 months and 12 months
measure: Number of Participants Who Changed Their Dietary Habits
timeFrame: 6 months and 12 months
measure: Physician Experience Questionnaire
timeFrame: At 6 months
measure: Change in Medication Possession Ratio
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic, Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Arshed Quyyumi, MD
role: PRINCIPAL_INVESTIGATOR
References: