Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05182359
Other study ID # STUDY20211340
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2022
Est. completion date March 31, 2023

Study information

Verified date May 2023
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Single-center, prospective, 2:1 randomized controlled parallel-group study, with an open label extension to evaluate SomaSignal Informed Medical Management (informed) versus Standard of Care (uninformed).


Description:

Primary Aim: To determine whether risk stratification from SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test leads to riskconcordant changes in prescriptions and/or medical management in patients with diabetes. Secondary Aims: Secondary Aim 1: To evaluate the perspectives of healthcare providers on the impact of SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test risk calculator in clinical practice. Secondary Aim 2: To enable future health economic analyses of the impact of precision risk-stratified treatment. Secondary Aim 3: In an open-label extension, to determine the impact of additional Metabolic Factor test results (beyond the SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D)) on medical management of the previously uninformed group at the end of the study.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 89 Years
Eligibility Inclusion Criteria: - Patients receiving care at a University Hospitals location - Patients 40-89 year of age - Diagnosis of Type 2 Diabetes Mellitus - Eligible for but not currently prescribed a SGLT2i or GLP1RA per drug label. This includes a diagnosis of type 2 diabetes plus established atherosclerotic cardiovascular disease or high risk for atherosclerotic cardiovascular disease (including age =55 years with coronary, carotid, or lower-extremity atherosclerotic disease) or heart failure or chronic kidney disease with or without albuminuria. - Patients that are able to provide consent Exclusion Criteria: - Intolerance or contraindication for use of both GLP1RA and SGLT2i - Use of SGLT2i or GLP1RA within the 3 months prior to enrollment - 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 - Patients that have Systemic Lupus Erythematous (SLE) - End-stage renal disease - Pregnancy (as determined by self-report) - Inability to understand English (since must be able to understand risk report which is not translated by the manufacturer)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test
The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test is used to predict the four-year likelihood of myocardial infarction, stroke, hospitalization for heart failure or death. It will be provided to the participant's ordering provider.

Locations

Country Name City State
United States University Hospitals Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center SomaLogic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Cost effectiveness of the SomaLogic CVD-T2D test in the Informed vs. Uninformed groups. Cost effectiveness of additional therapies measured by the incremental cost-effectiveness ratio utilizing the projected costs related to changes in prescription rates over the Quality Adjusted Life Years (QALYs), which reflects quality and quantity of life from cardiovascular event rate reductions estimated from the protein predicted risks. The incremental cost-effectiveness ratio is a way of investigating whether an intervention yields sufficient value to justify its cost. We will compare the Informed group to the Uninformed group, and find the difference in average cost, and differences in average effectiveness. The ratio is the incremental cost-effectiveness ratio (ICER). The recommended measure for effectiveness is Quality Adjusted Life Years (QALYs), which reflects quality and quantity of life. 1 year
Other The change in prescription rates of cardioprotective medications (SGLT2i or GLP1 RA) after revealing the CVD-T2D and Metabolic Factors test results at the end of the study in the Uninformed group. Medical record will be reviewed by the study team to evaluate changes in treatment strategy using the rate of new prescriptions for these medications. 20 weeks
Other The change in prescription rates of cardioprotective medications (SGLT2i or GLP1 RA) after revealing the Metabolic Factors test results at the end of the study in the Informed group. Medical record will be reviewed by the study team to evaluate changes in treatment strategy using the rate of new prescriptions for these medications. 20 weeks
Primary The relation of prescription rates of cardioprotective medications (SGLT2i or GLP1 RA) to CVD-T2D test risk assessment in the Informed group vs. Uninformed group. Medical record will be reviewed by the study team to evaluate changes in treatment strategy using the rate of new prescriptions for these medications. 12 weeks
Secondary Survey of healthcare providers on the impact of SomaLogic's CVD-T2D calculator on patient care, medication prescription, and risk perception. A survey will be obtained from the referring providers to assess perceived impact of the SomaLogic CVD-T2D test on risk. 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT05219994 - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum N/A
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Completed NCT02284893 - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone Phase 3
Completed NCT04274660 - Evaluation of Diabetes and WELLbeing Programme N/A
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Active, not recruiting NCT05566847 - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed NCT04965506 - A Study of IBI362 in Chinese Patients With Type 2 Diabetes Phase 2
Recruiting NCT06115265 - Ketogenic Diet and Diabetes Demonstration Project N/A
Recruiting NCT05979779 - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Obese Subjects With Type 2 Diabetes at Risk of Nonalcoholic Steatohepatitis Phase 2
Active, not recruiting NCT03982381 - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes Phase 4
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Completed NCT04023539 - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Completed NCT04097600 - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets Phase 1
Completed NCT05378282 - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Recruiting NCT06010004 - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Phase 3