Type 2 DiabetesNCT05166382
Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications
A study testing Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) and Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) in people with Type 2 Diabetes and Cardiovascular Diseases, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes, Cardiovascular Diseases
- What is being tested?
- Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) and Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Licensed provider actively practicing medicine at a UC Health clinic that routinely provides medical treatment for patients with type 2 diabetes
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications: An Adaptive Implementation Study
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.
- Conditions
- Type 2 Diabetes, Cardiovascular Diseases
- Being tested
- Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D), Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)
- Keywords
- Proteomics, T2D, Type 2 diabetes mellitus, CVD
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)Behavioural
Also called Informed
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.
Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)Behavioural
Also called Uninformed
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed) | Experimental | Blood draw for cardiovascular CVDT2D test at baseline and 6 months (+/- 30 days). SomaSignal Test results will be sent to the providers and then shared with study participants. Participants' medical record will be reviewed, and they may be contacted within 30 days after baseline and 6-month visits to review changes in treatment strategy (nothing, add/remove medication, etc.) made at visit. Receives: Behavioral: Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) |
| Group 2: Standard of Care (CVDT2D test, uninformed) | Placebo comparator | Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period. Receives: Behavioral: Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription rates of cardioprotective medications in the informed group vs uniformed group at 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.
Measured: Baseline
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6
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.
Measured: 6 months
Secondary outcomes (6)
Change in protein predicted risk: SomaLogic CVDT2D test
Longitudinal changes in protein-predicted risk as measured by SomaLogic CVDT2D test over 6 months
Measured: Baseline, 6 months
Change in protein predicted risk: biomarkers
Longitudinal changes in protein-predicted risk as measured by conventional biomarkers of risk over 6 months
Measured: Baseline, 6 months
Standard of care risk assessment: body mass index (BMI) at 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.
Measured: Baseline
Standard of care risk assessment: body mass index (BMI) at 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.
Measured: 6 months
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 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.
Measured: Baseline
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Providers will be randomized into informed vs uninformed groups. The randomization will occur at each clinic individually to assure equal distribution of informed vs uninformed providers in each clinic. Patients will be assigned a group based on their providers randomization.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- SomaLogic, Inc.
- Responsible party
- Sponsor
- Investigators
- Neda Rasouli, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166382
- Sponsor's protocol ID
- 21-4510
- Status last verified
- Mar 2025
- First submitted
- 8 Dec 2021
- Last updated
- 20 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SomaSignal Tests on the Choice of Glucose-lowering Medications: An Adaptive Implementation Study
- ClinicalTrials.gov ID
- NCT05166382
- Acronym / sponsor ID
- 21-4510
- Conditions
- Type 2 Diabetes, Cardiovascular Diseases
- Keywords
- Proteomics, T2D, Type 2 diabetes mellitus, CVD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- SomaLogic, Inc.
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Providers will be randomized into informed vs uninformed groups. The randomization will occur at each clinic individually to assure equal distribution of informed vs uninformed providers in each clinic. Patients will be assigned a group based on their providers randomization.
| Arm | Type | Receives |
|---|---|---|
| Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed) | Experimental | Behavioral: Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)Blood draw for cardiovascular CVDT2D test at baseline and 6 months (+/- 30 days). SomaSignal Test results will be sent to the providers and then shared with study participants. Participants' medical record will be reviewed, and they may be contacted within 30 days after baseline and 6-month visits to review changes in treatment strategy (nothing, add/remove medication, etc.) made at visit. |
| Group 2: Standard of Care (CVDT2D test, uninformed) | Placebo comparator | Behavioral: Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Licensed provider actively practicing medicine at a UC Health clinic that routinely provides medical treatment for patients with type 2 diabetes
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)Also: InformedProviders 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. | Behavioural | Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed) |
| Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D)Also: UninformedProviders 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. | Behavioural | Group 2: Standard of Care (CVDT2D test, uninformed) |
Primary outcome
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.
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.
6 secondary outcomes
Change in protein predicted risk: SomaLogic CVDT2D test
Time frame: Baseline, 6 months
Change in protein predicted risk: biomarkers
Time frame: Baseline, 6 months
Standard of care risk assessment: body mass index (BMI) at baseline
Time frame: Baseline
Standard of care risk assessment: body mass index (BMI) at 6 months
Time frame: 6 months
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at baseline
Time frame: Baseline
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Neda Rasouli, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) and Not informed of results from SomaSignal Cardiovascular Risk Test in Type 2 Diabetes (CVD-T2D) in people with Type 2 Diabetes and Cardiovascular Diseases, run by University of Colorado, Denver at 1 site 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 6 inclusion and 6 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline (time frame: Baseline). The study lists 2 primary outcomes in all. 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 20 Mar 2025.