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OpenTrials
Completed

NCT Number: NCT04557228

ADAM17 and Vascular Function in Diabetes

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.

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Key information

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri- NextGen Clinical Translational Science Unit

Columbia, Missouri, 65212, United States

About this study

As part of a randomized (1:1, experimental/placebo), double-blinded parallel design, each of the 34 subjects will complete 4 weeks (+/-4 days) of supplementation with either 900mg of a PS supplement or placebo. Assessment visits (2) will occur pre-intervention and post-intervention and include: 24-hour ambulatory blood pressure measurement (ABPM), Vitals, DEXA scan for body composition, fasting blood work, carotid-femoral pulse wave velocity (cfPWV), brachial and femoral artery FMDs, Femoral blood flow imaging during passive leg movement (PLM), glycocalyx integrity assessment via Glycocheck, and an oral glucose tolerance test (OGTT) with blood flow measurements and beat-to-beat sphygmomanometry via Finometer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Pregnancy
  • Bodyweight change ≥5% within the last 6 months

Treatment and study plan

Placebo

Dietary Supplement

4 weeks of placebo supplements

Phosphatidylserine

Dietary Supplement

4 weeks of phosphatidylserine supplements

Primary outcomes

  1. Change in Insulin-stimulated Blood Flow

    Time frame: baseline and 4 weeks

    Measure of blood flow during oral glucose tolerance test. Leg blood flow measures will be performed non-invasively via Ultrasound.

Secondary outcomes

  1. Percent Change in Vascular Function

    Time frame: Baseline and 4 weeks

    Flow mediated dilation (FMD) in arm and passive limb movement (PLM) in the leg. Blood flow measures will be performed non-invasively via Ultrasound.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Targeting ADAM17 Activity for Correction of Vascular Insulin Resistance in Type 2 Diabetes

Acronym: ADAM17

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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