An interventional study of SomaSignal Informed Medical Management SSCVD and Standard of Care in Diabetes Mellitus, Type 2, sponsored by Emory University. Completed at 5 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by Emory University · Not applicable, Interventional, and Diagnostic
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 143 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Blood draw for SSCVD test at baseline and 6 months (±50 days). SomaSignal Cardiovascular Risk (SSCVD) results will be sent to the providers and participants approximately 2-4 weeks after testing.
Diagnostic Test: SomaSignal Informed Medical Management SSCVD
Blood draw for SSCVD test at baseline and 6 months (±50 days). SomaSignal Cardiovascular Risk (SSCVD) results will not be provided to the provider or participant until the 6-month visit.
Other: Standard of Care
For participants randomized to the Informed arm, the SSCVD test results will be provided to the participant's clinicians approximately 2-4 weeks after the baseline blood draw. Clinicians will discuss results with the participant and make adjustments to the care plan as needed based on the SSCVD test results within 50 days of receiving results. Clinicians may advise participants to (i) either change the doses of existing medications within existing guidelines, (ii) prescribe additional guideline-based medications, (iii) advise additional lifestyle interventions, or (iv) advise no change. This information will be documented in the case report forms. This test is neither intended to diagnose cardiovascular disease (CVD) nor replace the standard of care protocols for this disease. The physician should not rely solely on this information to make a decision on the best course of action for this patient.
Also known as: SSCVD Informed
Clinicians will provide the standard of care based on routine test results and without the SSCVD results. The SSCVD and SomaSignal Metabolic Factor Panel results from participants from both the baseline and 6-month period will be provided to the study team at the 6-month study visit. The SomaSignal Metabolic Factor tests include evaluation of Liver Fat, Glucose Tolerance, Kidney Function, Alcohol Impact, Cardiorespiratory Fitness/oxygen consumption (VO2) max, Resting Energy Rate, Body Fat Percentage, Visceral Fat, and Lean Body Mass. Any recommendations made to the participant by the physicians, based on obtaining the aforementioned test results will be collected.
Also known as: Uninformed Arm
Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results
The number of participants with type 2 diabetes (T2D) who had changes in prescriptions aligned with SSCVD results at baseline will be reported for the informed group. For the uninformed group, this represents the number of participants who had prescription changes, even though the healthcare provider (HCP) was not informed of the results. SSCVD results from participants at both the baseline and 6-month periods will be provided to the study team during the 6-month study visit. Any recommendations made by physicians to participants, after these test results, will be collected. Medical records will be reviewed to assess any changes in treatment strategies.
Time frame: 6 months and 12 months after baseline
Number of Participants With Changes in the SSCVD Results
During the baseline and follow-up visits, participants will have blood samples drawn for the SSCVD test.
Time frame: Baseline and 6 months
Changes in Low-density Lipoprotein (LDL)
A blood sample to measure LDL will be drawn during the baseline and follow-up visits. Electronic medical records (EMR) will also be reviewed.
Time frame: 6 months and 12 months
Changes in High-density Lipoprotein (HDL)
A blood sample to measure HDL will be drawn during the baseline and follow-up visits. EMR Records will also be reviewed
Time frame: 6 months and 12 months
Changes in Triglycerides (TG) Levels
A blood sample to measure TG will be drawn during the baseline and follow-up visits. EMR Records will also be reviewed.
Time frame: 6 months and 12 months
Changes in Glucose Levels
A blood sample to measure glucose will be drawn during the baseline and follow-up visits. EMR records will also be reviewed.
Time frame: 6 months and 12 months
Changes in Glycated Hemoglobin Test (HbA1C)
A blood sample to measure HbA1C will be drawn during the baseline and follow-up visits.
Time frame: 6 months and 12 months
Changes in Weight
Weight will be measured in kilograms (kg) during baseline and follow-up visits. EMR records will also be reviewed.
Time frame: 6 months and 12 months
Changes in Body Mass Index (BMI)
Height will be measured in meters (m) during the baseline visit, and weight will be measured during the baseline and follow-up visits. BMI will be calculated at each visit using the formula: weight (kg) / \[height (m)\]\^2. EMR will also be reviewed.
Time frame: 6 months and 12 months
Number of Participants Who Experienced Changes in Tobacco Exposure
Participants will complete a questionnaire on personal tobacco use and exposure to second-hand smoke at both the baseline and follow-up visits. Responses are provided as categorical, multiple-choice options, and no summary score will be calculated for tobacco exposure. Data will also be extracted from the EMR.
Time frame: 6 months and 12 months
Number of Participants Who Experienced a Change in Physical Activity
A questionnaire will be provided at baseline and follow-up visit asking about physical activity habits. The questionnaire asks respondents how active they are during leisure time and has four response options: * Mainly sedentary (e.g. sitting, reading, watching television) * Mild exercise, minimal effort (eg. yoga, archery, sport fishing, easy walking at least 3 times per week) * Moderate exercise (eg. walking, bicycle riding, or light gardening at least 4 hours per week) * Strenuous exercise (heart beats rapidly e.g. running/jogging, football, vigorous swimming at least 3 times per week) A summary score is not calculated for this assessment. Data will also be extracted from EMR.
Time frame: 6 months and 12 months
Number of Participants Who Changed Their Dietary Habits
Dietary habits will be assessed with a 5-item asking about consumption of salty foods, deep fried foods, fruits, vegetables, and meat/poultry. Responses are given as yes or no. There is not a summary score generated for this questionnaire.
Time frame: 6 months and 12 months
Physician Experience Questionnaire
The physician questionnaire will ask 6 to 8 open ended and multiple choice questions regarding changes to treatment plans, identification of unexpected higher risk patients patients, and frequency of testing preferences. There is not a summary score generated for this qualitative questionnaire.
Time frame: At 6 months
Change in Medication Possession Ratio
Participant adherence to medications will be quantified using the medication possession ratio which is the number of prescriptions filled divided by the number of months participants are prescription eligible.
Time frame: Baseline and 6 months
Participants were recruited from Emory Healthcare System in Atlanta, Georgia, USA. Participant enrollment began February 03, 2022, and all follow-up was complete by December 9, 2023.
| Milestone | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Started | 73 | 70 |
| Completed | 54 | 56 |
| Not completed | 19 | 14 |
| Withdrew: Lost to follow-up | 9 | 3 |
| Withdrew: Withdrawal by subject | 7 | 11 |
| Withdrew: Screen failures | 3 | 0 |
The number of participants with type 2 diabetes (T2D) who had changes in prescriptions aligned with SSCVD results at baseline will be reported for the informed group. For the uninformed group, this represents the number of participants who had prescription changes, even though the healthcare provider (HCP) was not informed of the results. SSCVD results from participants at both the baseline and 6-month periods will be provided to the study team during the 6-month study visit. Any recommendations made by physicians to participants, after these test results, will be collected. Medical records will be reviewed to assess any changes in treatment strategies.
| Participants | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six months after baseline | 45 | 13 |
| Twelve months after baseline | 8 | 35 |
During the baseline and follow-up visits, participants will have blood samples drawn for the SSCVD test.
| Participants | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Baseline — Low Risk | 6 | 6 |
| Baseline — Medium-Low Risk | 23 | 27 |
| Baseline — Medium-High Risk | 18 | 22 |
| Baseline — HIgh Risk | 23 | 15 |
| 6 months — Low Risk | 7 | 1 |
| 6 months — Medium-Low Risk | 19 | 23 |
| 6 months — Medium-High Risk | 13 | 16 |
| 6 months — HIgh Risk | 15 | 16 |
A blood sample to measure LDL will be drawn during the baseline and follow-up visits. Electronic medical records (EMR) will also be reviewed.
| mg/dL | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six months after baseline | -30 ± 5 | -12 ± 8 |
| Twelve months after baseline | -45 ± 4 | 25 ± 6 |
A blood sample to measure HDL will be drawn during the baseline and follow-up visits. EMR Records will also be reviewed
| mg/dL | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six months after baseline | 5 ± 1.5 | 2 ± 2.0 |
| Twelve months after baseline | 8 ± 1.2 | 4 ± 2.5 |
A blood sample to measure TG will be drawn during the baseline and follow-up visits. EMR Records will also be reviewed.
| mg/dL | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six months after baseline | -60 ± 5 | -15 ± 10 |
| Twelve months after baseline | -15 ± 2 | -45 ± 15 |
A blood sample to measure glucose will be drawn during the baseline and follow-up visits. EMR records will also be reviewed.
| mg/dL | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six months after baseline | -45 ± 4 | 10 ± 8 |
| Twelve months after baseline | -10 ± 8 | 35 ± 12 |
A blood sample to measure HbA1C will be drawn during the baseline and follow-up visits.
| percent of RBCs with glycated hemoglobin | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six months after baseline | -1.8 ± 1.3 | 0.8 ± 0.2 |
| Twelve months after baseline | -2.2 ± 1.2 | -2.4 ± 1 |
Weight will be measured in kilograms (kg) during baseline and follow-up visits. EMR records will also be reviewed.
| Kilograms | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six months after baseline | -6.37 ± 0.4 | 0.87 ± 0.3 |
| Twelve months after baseline | -3.47 ± 0.2 | -3.18 ± 01 |
Height will be measured in meters (m) during the baseline visit, and weight will be measured during the baseline and follow-up visits. BMI will be calculated at each visit using the formula: weight (kg) / \[height (m)\]\^2. EMR will also be reviewed.
| kg/m^2 | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six months after baseline | -2.2 ± 0.4 | 0.3 ± 0.2 |
| 12 months after baseline | -1.2 ± 0.3 | 1.1 ± 0.1 |
Participants will complete a questionnaire on personal tobacco use and exposure to second-hand smoke at both the baseline and follow-up visits. Responses are provided as categorical, multiple-choice options, and no summary score will be calculated for tobacco exposure. Data will also be extracted from the EMR.
| Participants | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six months after baseline | 3 | 1 |
| Twelve months after baseline | 10 | 5 |
A questionnaire will be provided at baseline and follow-up visit asking about physical activity habits. The questionnaire asks respondents how active they are during leisure time and has four response options: * Mainly sedentary (e.g. sitting, reading, watching television) * Mild exercise, minimal effort (eg. yoga, archery, sport fishing, easy walking at least 3 times per week) * Moderate exercise (eg. walking, bicycle riding, or light gardening at least 4 hours per week) * Strenuous exercise (heart beats rapidly e.g. running/jogging, football, vigorous swimming at least 3 times per week) A summary score is not calculated for this assessment. Data will also be extracted from EMR.
| Participants | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six month safter baseline | 25 | 3 |
| Twelve months after baseline | 12 | 19 |
Dietary habits will be assessed with a 5-item asking about consumption of salty foods, deep fried foods, fruits, vegetables, and meat/poultry. Responses are given as yes or no. There is not a summary score generated for this questionnaire.
| Participants | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Six months after baseline | 25 | 3 |
| Twelve months after baseline | 12 | 19 |
The physician questionnaire will ask 6 to 8 open ended and multiple choice questions regarding changes to treatment plans, identification of unexpected higher risk patients patients, and frequency of testing preferences. There is not a summary score generated for this qualitative questionnaire.
No measurements were reported for this outcome.
Participant adherence to medications will be quantified using the medication possession ratio which is the number of prescriptions filled divided by the number of months participants are prescription eligible.
No measurements were reported for this outcome.
Collected over Information on adverse events was collected from the time consent to participate in the study was given until 6 months after consent.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SomaSignal Informed Medical Management SSCVD | 0/73 (0%) | 1/73 (1.4%) | 0/73 (0%) |
| Standard of Care (Uninformed Arm) | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
| Event | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) |
|---|---|---|
| Non related hospital admissionMetabolism and nutrition disorders | 1/73 | 0/70 |
| Age, Categorical(Participants) | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 22 | 47 |
| >=65 years | 48 | 48 | 96 |
| Age, Continuous(years) | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) | Total |
|---|---|---|---|
| Mean | 68.63 ± 10.16 | 67.66 ± 9.79 | 68.15 ± 9.96 |
| Sex: Female, Male(Participants) | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) | Total |
|---|---|---|---|
| Female | 35 | 32 | 67 |
| Male | 38 | 38 | 76 |
| Race (NIH/OMB)(Participants) | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 7 | 9 | 16 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 34 | 31 | 65 |
| White | 31 | 29 | 60 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | SomaSignal Informed Medical Management SSCVD | Standard of Care (Uninformed Arm) | Total |
|---|---|---|---|
| United States | 73 | 70 | 143 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Researchers will share data after the completion of the trial and publications are completed. The research team will share de-identified data on patient demographics, outcomes, and SomaSignal Test Results.
Supporting information: Study protocol, Sap
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Emory University