What side effects are associated with this type of intervention?

Common treatments for health behaviors, such as those potentially informed by the SomaSignal Test, include lifestyle modifications, medications, and non-pharmacological interventions. Lifestyle changes usually have minimal side effects but may involve temporary discomfort or adjustment issues. Medications can cause gastrointestinal issues, headaches, or more severe reactions like cardiovascular problems. Non-pharmacological interventions, such as cognitive-behavioral therapy, generally have fewer side effects but may include emotional discomfort as patients address challenging issues.

What prior FDA approvals exist?

The FDA has approved various treatments aimed at modifying health behaviors, particularly in the context of managing chronic conditions such as obesity and cardiovascular diseases. For instance, drugs like semaglutide have been approved for weight management in individuals with obesity or overweight, demonstrating significant weight loss in clinical trials. Additionally, genomic and biomarker-linked therapies have been approved for certain cancers, providing personalized treatment plans based on blood sample analysis. These approaches align with the principles of the SomaSignal Test, which analyzes blood samples to offer actionable medical insights for managing cardiovascular disease risk.

What other types of research exist?

Promising novel alternatives to the SomaSignal Test for health behavior patients include: 1) Noninvasive neuromodulation devices, which have shown efficacy in conditions like essential tremor and could be adapted for broader health behavior monitoring. 2) Wearable technologies for continuous health monitoring, which can track various physiological parameters and provide real-time feedback. 3) Advanced serologic tests and imaging examinations for noninvasive assessment of conditions like hepatic fibrosis, which can offer detailed insights into patient health without the need for invasive procedures.

← Back to Search

SomaSignal Tests for Cardiovascular Disease Risk Management (SomaSignal Trial)

N/A

Recruiting

Research Sponsored by Intermountain Health Care, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female 40 - 80 years of age

Be older than 18 years old

Must not have

Presence of Systemic Lupus Erythematosus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses the SomaSignal Test to analyze blood samples and provide health information. It targets patients to see if this test can help guide medical decisions. The test works by examining proteins in the blood to give doctors useful health insights.

Who is the study for?

This trial is for men and women aged 40-80 who are at a higher risk of heart problems, can give informed consent, agree to blood tests, and share their health records. They must be patients at Intermountain Medical Center and able to attend follow-up visits. Pregnant individuals or those with certain conditions like Systemic Lupus Erythematosus or recent participation in other trials cannot join.

What is being tested?

The study is testing the impact of knowing one's SomaSignal Test results on managing heart disease risk. Initially, 12 people will get their results without randomization. Then, 200 more will be randomly assigned (2:1 ratio) to either learn about their test outcomes or not until after six months.

What are the potential side effects?

Since this trial involves only diagnostic tests rather than medications or invasive procedures, typical side effects associated with drugs are not expected. However, minor risks may include discomfort from blood draws.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with Systemic Lupus Erythematosus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Porportion of participants that undergo a change in their treatment plan after receipt of the SomaSignal test.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InformedExperimental Treatment1 Intervention

Blood draw for SomaSignal Test and laboratory assessments at baseline, and 6 months (±30 days); SomaSignal Test results to be sent to investigators as available. Review and discussion of results with the participant from baseline and 6 months within 30 days (2-4 weeks to get SomaSignal results) after blood draw. Initiation of changes in medical management as soon as test results are known and discussed with patient. Patients will have a blood draw performed at baseline and 6 months for lipid panel, hemoglobin A1C, CBC, and BMP.

Group II: UninformedActive Control1 Intervention

Blood draw for SomaSignal Test at baseline and 6 months (+30 days). However, results will not be provided to clinician and participant until study conclusion. Patients contacted within 30 days (2-4 weeks) after baseline and 6-month visits to discuss treatment strategy (nothing, add/ remove medication, etc.) made at visit. Patients will have a blood draw performed at baseline and for lipid panel, hemoglobin A1C, CBC, and BMP SomaSignal Test results to be sent to investigators AFTER study conclusion. Patients will be provided with SomaSignal Test results after the 6 month post-test timepoint.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for health behaviors often involve personalized medicine approaches, such as the SomaSignal Test, which analyzes blood samples to provide specific medical insights and guide treatment decisions. This method helps in tailoring interventions to the individual's unique biological profile, thereby enhancing the effectiveness of the treatment. Additionally, behavioral treatments like exercise and mindfulness work by improving physical and mental health through physiological and psychological mechanisms, such as reducing stress and enhancing mood. Pharmacotherapy, on the other hand, targets specific biochemical pathways to manage symptoms and improve overall health. These treatments are crucial for health behavior patients as they offer targeted, effective strategies to manage and improve their conditions, leading to better health outcomes.

Acceptance and commitment therapy (ACT) for adult type 1 diabetes management: study protocol for a randomised controlled trial.Evidence-based psychosocial treatments for children and adolescents exposed to traumatic events.