Your session is about to expire
← Back to Search
SomaSignal Tests for Type 2 Diabetes Care
N/A
Waitlist Available
Led By Neda Rasouli, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will assess whether the SomaSignal CV Risk Test can help improve patient care by providing more information to doctors about a patient's individual risk for CV disease.
Who is the study for?
This trial is for adults over 40 with Type 2 Diabetes receiving care at a UC Health system, who can consent and are eligible for certain diabetes medications. It excludes those intolerant to these meds, pregnant women, recent users of the drugs in question, people with systemic lupus or a significant cancer history within the last five years.Check my eligibility
What is being tested?
The study tests if knowing one's SomaSignal Cardiovascular Risk Test results affects doctors' choice of glucose-lowering medications for patients with Type 2 Diabetes and cardiovascular disease risk.See study design
What are the potential side effects?
Since this trial involves informing participants about test results rather than administering drugs directly, it does not have direct side effects. However, changes in medication based on test results may lead to typical drug-related side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Baseline
Prescription rates of cardioprotective medications in the informed group vs uniformed group at Month 6
Secondary outcome measures
Change in protein predicted risk: SomaLogic CVDT2D test
Change in protein predicted risk: biomarkers
Standard of care risk assessment: Atherosclerotic Cardiovascular Disease risk calculator (ASCVD) at 6 months
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed)Experimental Treatment1 Intervention
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 II: Group 2: Standard of Care (CVDT2D test, uninformed)Placebo Group1 Intervention
Similar to group 1 but SomaSignal CV test results will not be provided to participants until after the intervention period.
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,739 Previous Clinical Trials
2,149,795 Total Patients Enrolled
SomaLogic, Inc.Industry Sponsor
6 Previous Clinical Trials
988 Total Patients Enrolled
Neda Rasouli, MDPrincipal InvestigatorUniversity of Colorado, Denver
2 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot use both GLP1RA and SGLT2i medications due to intolerance or medical reasons.You have taken certain types of diabetes or cholesterol medications in the last 3 months.You are 40 years old or older.You have systemic lupus erythematosus (SLE).You have type 2 diabetes.If you have lupus, the test results might not be accurate because the antibodies in your blood could affect the testing materials.You are considered suitable for treatment with at least one of the following types of medications: SGLT2 inhibitors, PCSK9 inhibitors, or GLP-1 receptor agonists.You have had cancer that is not basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer within the last 5 years, or you are currently getting treatment for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: SomaSignal Informed Medical Management (CVDT2D test, informed)
- Group 2: Group 2: Standard of Care (CVDT2D test, uninformed)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aim of this research endeavor?
"This research seeks to assess the prescription rate of cardioprotective medication among informed and uninformed groups after six months. Secondary objectives include a longitudinal analysis of protein-predicted risk through SomaLogic CVDT2D testing, as well as BMI and ASCVD assessments at baseline."
Answered by AI
How many participants are receiving treatment as part of this investigation?
"Affirmative. Clinicaltrials.gov's records reveal that this trial, which was posted on the first day of 2021, is actively recruiting volunteers. The research team needs to recruit 350 individuals from 2 sites in total."
Answered by AI
Are there any available vacancies in this research effort?
"Affirmative, information available at clinicaltrials.gov reveals that this trial is enlisting patients for participation. This research was initially posted on January 1st 2022 and updated lastly on April 12th 2022. A total of 350 participants are needed from 2 study sites."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger