CompletedNot Applicable

ADAM17 and Vascular Function in Diabetes

United States36 participantsStarted 2023-03-01

Plain-language summary

The objective of this project is to determine the extent to which administration of the dietary supplement phosphatidylserine (PS), a competitive inhibitor of ADAM17 sheddase activity, effects vascular function and insulin-stimulated leg blood flow in subjects with T2D.

Who can participate

Age range

45 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men and women with a BMI of 25-39 kg/m2, who are 45-64 years of age at randomization.
. T2D patients classified based on physician diagnosis.
. No vulnerable populations (e.g., prisoners, pregnant, children) will be enrolled.

Exclusion criteria

. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke
. History of chronic renal or hepatic disease
. Active cancer
. Autoimmune diseases
. Immunosuppressant therapy
. Hormone replacement therapy
. Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
. Current tobacco use

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Insulin-stimulated Blood Flow

Timeframe: baseline and 4 weeks

Trial details

NCT IDNCT04557228

SponsorUniversity of Missouri-Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-03

Results submitted2026-02-24

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials