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Proteomic Test
SomaSignal Tests for Diabetes
N/A
Waitlist Available
Led By Arshed Quyyumi, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of T2D according to American Diabetes Association (ADA) guidelines
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
Study Summary
This trial found that the use of a 27-protein model, encompassing ten biological systems, was able to accurately predict who would benefit from a novel glycemia-lowering therapy.
Who is the study for?
This trial is for men and women over 40 with Type 2 Diabetes who can consent to treatment. They should be eligible for certain diabetes drugs (SGLT2i, PCSK9i, GLP-1 RA) but not currently on them or only on PCSK9i. Excluded are those who don't understand English, have lupus, are pregnant, can't take the study drugs due to intolerance or contraindications, or have a recent or active cancer.Check my eligibility
What is being tested?
The trial tests if SomaSignal Informed Medical Management (using a proteomic test called SSCVR) improves cardiovascular risk management in diabetic patients compared to standard care. It aims to personalize treatment by assessing individual protein levels related to heart health.See study design
What are the potential side effects?
While specific side effects aren't listed here, the interventions involve diabetes medications that may include risks like urinary infections from SGLT2 inhibitors, potential allergic reactions from GLP-1 receptor agonists and possible injection site reactions from PCSK9 inhibitors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type 2 Diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in prescriptions of participants with type 2 diabetes (T2D) in concordance with SSCVD results over a 6-month period
Secondary outcome measures
Change in medication possession ratio
Changes in CVD risk factors measured by Body Mass Index (BMI)
Changes in CVD risk factors measured by weight
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SomaSignal Informed Medical Management SSCVDExperimental Treatment1 Intervention
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.
Group II: Standard of Care (Uninformed Arm)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SomaSignal Informed Medical Management SSCVD
2022
N/A
~150
Who is running the clinical trial?
SomaLogic, Inc.Industry Sponsor
6 Previous Clinical Trials
1,195 Total Patients Enrolled
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,389 Total Patients Enrolled
Arshed Quyyumi, MDPrincipal InvestigatorEmory University
11 Previous Clinical Trials
2,286 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am eligible for SGLT2i, PCSK9i, or GLP-1 RA drugs but currently not taking them, or only taking PCSK9i.I am 40 years old or older.I have been diagnosed with Type 2 Diabetes.I have been diagnosed with Systemic Lupus Erythematosus (SLE).I cannot tolerate or am advised against using GLP-1 RA, SGLT2i, and PCSK9i medications.I have been cancer-free for less than 5 years or am currently receiving cancer treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any current opportunities to take part in this research?
"According to official records listed on clinicaltrials.gov, this medical trail is currently recruiting individuals for participation. The trial was originally posted on February 3rd 2022 and the most recent update was made on the 15th of that same month."
Answered by AI
How many volunteers are taking part in this experiment?
"Affirmative. According to the documentation hosted on clinicaltrials.gov, this medical trial was initially listed on February 3rd 2022, and is actively in pursuit of 450 participants from 5 different centres."
Answered by AI
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