What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include GLP-1 receptor agonists, SGLT2 inhibitors, and DPP-4 inhibitors. GLP-1 receptor agonists can cause gastrointestinal issues such as nausea, vomiting, and diarrhea, and have been associated with an increased risk of pancreatitis. SGLT2 inhibitors may lead to urinary tract infections, genital infections, and an increased risk of diabetic ketoacidosis. DPP-4 inhibitors are generally well-tolerated but can cause nasopharyngitis, headaches, and a potential risk of pancreatitis. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of Type 2 Diabetes (T2D). These include GLP-1 receptor agonists like dulaglutide, which improve glycemic control and have cardiovascular benefits. SGLT2 inhibitors such as dapagliflozin help lower blood glucose levels by promoting glucose excretion through urine and have shown benefits in reducing cardiovascular events. Other approved treatments include DPP-4 inhibitors, which increase incretin levels to stimulate insulin release, and traditional medications like metformin, which improves insulin sensitivity. While phosphatidylserine's role as a competitive inhibitor of ADAM17 sheddase activity is under investigation, it represents a novel approach that is not yet reflected in current FDA-approved treatments.

What other types of research exist?

Currently, there are no specific alternatives to phosphatidylserine mentioned for competitive inhibition of ADAM17 sheddase activity in T2D patients. Patients should consult their healthcare provider for the latest treatment options and consider other emerging therapies for T2D that may improve vascular function and insulin sensitivity.

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Competitive Inhibitor

Phosphatidylserine for Type 2 Diabetes (ADAM17 Trial)

N/A

Recruiting

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

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

Must have

Men and women with a BMI of 25-39 kg/m2, who are 45-64 years of age at randomization

Be between 18 and 65 years old

Must not have

Hormone replacement therapy

Cardiovascular disease including myocardial infarction, heart failure, coronary artery disease, stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 4 weeks

Summary

This trial is testing a dietary supplement called phosphatidylserine to see if it can help improve blood flow in people with Type 2 Diabetes. The supplement works by blocking an enzyme that affects blood vessels. Researchers will compare the effects of the supplement over a period of time.

Who is the study for?

This trial is for men and women aged 45-64 with Type 2 Diabetes, a BMI of 25-39 kg/m2, and no recent significant weight change. It excludes those with active cancer, autoimmune diseases, heavy alcohol use, chronic kidney or liver disease, current smokers, cardiovascular conditions, on immunosuppressants or hormone therapy.

What is being tested?

The study tests if phosphatidylserine (PS), a dietary supplement that inhibits ADAM17 enzyme activity can improve blood flow and vascular function in people with Type 2 Diabetes. Participants will either receive PS or a placebo to compare effects.

What are the potential side effects?

While the side effects of phosphatidylserine are not detailed here, common ones may include stomach upset and insomnia. Placebos typically have no active ingredients but can cause perceived side effects due to expectations.

Eligibility Criteria

Inclusion Criteria

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

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I am between 45-64 years old with a BMI of 25-39.

Exclusion Criteria

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

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I am on hormone replacement therapy.

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I have a history of heart disease, including heart attack or stroke.

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I have a long-term kidney or liver disease.

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My cancer is currently active.

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I am currently on immunosuppressant therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Insulin-stimulated blood flow

Secondary study objectives

Change in Vascular function

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Phosphatidylserine SupplementationExperimental Treatment1 Intervention

Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements.

Group II: PlaceboPlacebo Group1 Intervention

Study participants will receive 4 weeks of supplementation with 900mg placebo supplements

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Phosphatidylserine

2020

Completed Phase 2

~240

0 / 6Eligibility 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

Common treatments for Type 2 Diabetes (T2D) include metformin, which reduces hepatic glucose production and improves insulin sensitivity; sulfonylureas, which increase insulin secretion from pancreatic beta cells; and GLP-1 receptor agonists, which enhance insulin secretion, inhibit glucagon release, and slow gastric emptying. Phosphatidylserine, a competitive inhibitor of ADAM17 sheddase activity, is being studied for its potential to improve vascular function and insulin-stimulated blood flow in T2D patients. Understanding these mechanisms is crucial for T2D patients as they target different aspects of the disease, helping to manage blood glucose levels, reduce complications, and improve overall vascular health.

Factors Associated with Poor Glycemic and Lipid Levels in Ambulatory Diabetes Mellitus Type 2 Patients in Asmara, Eritrea: A Cross-Sectional Study.No common denominator: Plant-based diets and treatment-induced neuropathy of diabetes.Inflammatory cytokines in type 2 diabetes mellitus as facilitators of hypercoagulation and abnormal clot formation.