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CompletedNCT04557228ADAM17Updated May 4, 2026Results posted

ADAM17 and Vascular Function in Diabetes

An interventional study of Placebo and Phosphatidylserine in Diabetes Mellitus, Type 2, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 45 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
45 Years to 64 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • endothelial dysfunction
  • vascular function
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 36 is below the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke
  2. History of chronic renal or hepatic disease
  3. Active cancer
  4. Autoimmune diseases
  5. Immunosuppressant therapy
  6. Hormone replacement therapy
  7. Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)
  8. Current tobacco use
  9. Pregnancy
  10. Bodyweight change ≥5% within the last 6 months
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Placebo comparator
    Placebo

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

    Dietary Supplement: Placebo

  • Experimental
    Phosphatidylserine Supplementation

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

    Dietary Supplement: Phosphatidylserine

Interventions

  • Dietary supplementPlacebo

    4 weeks of placebo supplements

  • Dietary supplementPhosphatidylserine

    4 weeks of phosphatidylserine supplements

06

What researchers measure

Primary outcomes

  1. Change in Insulin-stimulated Blood Flow

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

    Time frame: baseline and 4 weeks

Secondary outcomes

  1. Percent Change in Vascular Function

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

    Time frame: Baseline and 4 weeks

07

Results

Posted May 4, 2026

Participant flow

Participant flow — Overall Study
MilestonePlaceboPhosphatidylserine Supplementation
Started1917
Completed1816
Not completed11

Outcome measures

PrimaryChange in Insulin-stimulated Blood Flow

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

Time frame:
baseline and 4 weeks
Reported as:
Mean · mL/min
Change in Insulin-stimulated Blood Flow
mL/minPlaceboPhosphatidylserine Supplementation
Change in Insulin-stimulated Blood Flow-70.80 ± 264.8724.79 ± 174.76
SecondaryPercent Change in Vascular Function

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

Time frame:
Baseline and 4 weeks
Reported as:
Mean · Percent Change in Vascular function
Percent Change in Vascular Function
Percent Change in Vascular functionPlaceboPhosphatidylserine Supplementation
Percent Change in Vascular Function0.54 ± 1.590.41 ± 1.68

Adverse events

Collected over baseline (day 0) to final (week 4). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/19 (0%)2/19 (10.5%)6/19 (31.6%)
Phosphatidylserine Supplementation0/17 (0%)2/17 (11.8%)2/17 (11.8%)
Most frequent serious events
Most frequent serious events
EventPlaceboPhosphatidylserine Supplementation
HypertensionCardiac disorders2/192/17
Most frequent other events
Most frequent other events
EventPlaceboPhosphatidylserine Supplementation
NeuropathyNervous system disorders0/191/17
Supraventricular arrhythmia NOSCardiac disorders0/191/17
Covid-19 InfectionGeneral disorders1/190/17
HyperglycemiaEndocrine disorders1/190/17
HypersensitivityImmune system disorders1/190/17
ConstipationGastrointestinal disorders1/190/17
NauseaGastrointestinal disorders1/190/17
Vein ruptureGeneral disorders1/190/17

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PlaceboPhosphatidylserine SupplementationTotal
<=18 years000
Between 18 and 65 years191736
>=65 years000
Age, Continuous
Age, Continuous(years)PlaceboPhosphatidylserine SupplementationTotal
Mean53 ± 6.456 ± 4.755 ± 5.9
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPhosphatidylserine SupplementationTotal
Female7714
Male121022
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboPhosphatidylserine SupplementationTotal
Hispanic or Latino202
Not Hispanic or Latino171633
Unknown or Not Reported011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboPhosphatidylserine SupplementationTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American123
White171532
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)PlaceboPhosphatidylserine SupplementationTotal
United States191736
08

Study locations

1 site
  • University of Missouri- NextGen Clinical Translational Science Unit
    Columbia, Missouri 65212, United States
09

References and documents

Study documents

  • Study protocol · Jul 17, 2024
  • Statistical analysis plan · Jul 17, 2024
  • Informed consent form · Jul 24, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04557228
Lead sponsor
University of Missouri-Columbia
Responsible party
Luis Martinez-Lemus, DVM, PhD (Professor in Medical Pharmacology Physiology, University of Missouri-Columbia) — Principal investigator
First posted
Sep 21, 2020
Start date
Mar 1, 2023
Primary completion
Feb 3, 2025
Completion
Nov 1, 2025
Results posted
May 4, 2026
Last update
May 4, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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