Status:
COMPLETED
SomaSignal Tests on Medical Management and Change in Risk in Patients With Diabetes
Lead Sponsor:
Emory University
Collaborating Sponsors:
SomaLogic, Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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-l...
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 person...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.)
Key Trial Info
Start Date :
February 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2023
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT05256706
Start Date
February 3 2022
End Date
December 9 2023
Last Update
January 9 2025
Active Locations (5)
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1
Grady Health System
Atlanta, Georgia, United States, 30303
2
Emory Hospital Midtown
Atlanta, Georgia, United States, 30308
3
Emory Clinic, Emory University Hospital
Atlanta, Georgia, United States, 30322
4
Emory Hospital
Atlanta, Georgia, United States, 30322