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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
Awards & highlights

Summary

This trial will test whether the dietary supplement phosphatidylserine can improve vascular function and insulin-stimulated blood flow in people with type 2 diabetes.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Insulin-stimulated blood flow
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
367 Previous Clinical Trials
628,383 Total Patients Enrolled

Media Library

Phosphatidylserine (Competitive Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04557228 — N/A
Type 2 Diabetes Research Study Groups: Placebo, Phosphatidylserine Supplementation
Type 2 Diabetes Clinical Trial 2023: Phosphatidylserine Highlights & Side Effects. Trial Name: NCT04557228 — N/A
Phosphatidylserine (Competitive Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04557228 — N/A
~13 spots leftby Jun 2025