Diabetes Mellitus, Type 2NCT05256706
SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes
A study testing SomaSignal Informed Medical Management SSCVD in people with Diabetes Mellitus, Type 2, run by Emory University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- SomaSignal Informed Medical Management SSCVD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Feb 2022to 9 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Grady Health System
Atlanta, Georgia, 30303
Emory Hospital Midtown
Atlanta, Georgia, 30308
Emory Clinic, Emory University Hospital
Atlanta, Georgia, 30322
Emory Hospital
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- SomaSignal Informed Medical Management SSCVD, Standard of Care
- Keywords
- cardiovascular risk
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomaSignal Informed Medical Management SSCVDDiagnostic test
Also called SSCVD Informed
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.
Standard of CareOther
Also called Uninformed Arm
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.
| Study group | Role | What they receive |
|---|---|---|
| SomaSignal Informed Medical Management SSCVD | Experimental | 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. Receives: Diagnostic Test: SomaSignal Informed Medical Management SSCVD |
| Standard of Care (Uninformed Arm) | Active comparator | 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months and 12 months after baseline
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start3 Feb 2022
- Primary completion9 Dec 2023
- Study completion9 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- SomaLogic, Inc.
- Responsible party
- Principal investigator, Arshed A. Quyyumi, Emory University
- Investigators
- Arshed Quyyumi, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256706
- Sponsor's protocol ID
- STUDY00003362
- Status last verified
- Dec 2024
- First submitted
- 20 Jan 2022
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05256706
- Acronym / sponsor ID
- STUDY00003362
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- SomaLogic, Inc.
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 9 Dec 2023 (actual)
- Study completion
- 9 Dec 2023 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SomaSignal Informed Medical Management SSCVD | Experimental | Diagnostic Test: SomaSignal Informed Medical Management SSCVDBlood 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. |
| Standard of Care (Uninformed Arm) | Active comparator | Other: Standard of CareBlood 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomaSignal Informed Medical Management SSCVDAlso: SSCVD InformedFor 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. | Diagnostic test | SomaSignal Informed Medical Management SSCVD |
| Standard of CareAlso: Uninformed ArmClinicians 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. | Other | Standard of Care (Uninformed Arm) |
Primary outcome
Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results
Time frame: 6 months and 12 months after baseline
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.
13 secondary outcomes
Number of Participants With Changes in the SSCVD Results
Time frame: Baseline and 6 months
Changes in Low-density Lipoprotein (LDL)
Time frame: 6 months and 12 months
Changes in High-density Lipoprotein (HDL)
Time frame: 6 months and 12 months
Changes in Triglycerides (TG) Levels
Time frame: 6 months and 12 months
Changes in Glucose Levels
Time frame: 6 months and 12 months
Changes in Glycated Hemoglobin Test (HbA1C)
Time frame: 6 months and 12 months
Changes in Weight
Time frame: 6 months and 12 months
Changes in Body Mass Index (BMI)
Time frame: 6 months and 12 months
Number of Participants Who Experienced Changes in Tobacco Exposure
Time frame: 6 months and 12 months
Number of Participants Who Experienced a Change in Physical Activity
Time frame: 6 months and 12 months
Number of Participants Who Changed Their Dietary Habits
Time frame: 6 months and 12 months
Physician Experience Questionnaire
Time frame: At 6 months
Change in Medication Possession Ratio
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arshed Quyyumi, MD principal investigator
Emory University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SomaSignal Informed Medical Management SSCVD in people with Diabetes Mellitus, Type 2, run by Emory University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Type 2 Diabetes (T2D) Who Had Prescription Changes in Concordance With SSCVD Results (time frame: 6 months and 12 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.