Diabetes Mellitus, Type 2ADAM17NCT04557228
ADAM17 and Vascular Function in Diabetes
A study testing Phosphatidylserine in people with Diabetes Mellitus, Type 2, run by University of Missouri-Columbia at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Phosphatidylserine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri- NextGen Clinical Translational Science Unit
Columbia, Missouri, 65212
About this study
Official title: Targeting ADAM17 Activity for Correction of Vascular Insulin Resistance in Type 2 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.
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo, Phosphatidylserine
- Keywords
- endothelial dysfunction, vascular function
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
4 weeks of placebo supplements
PhosphatidylserineDietary supplement
4 weeks of phosphatidylserine supplements
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Study participants will receive 4 weeks of supplementation with 900mg placebo supplements Receives: Dietary Supplement: Placebo |
| Phosphatidylserine Supplementation | Experimental | Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. Receives: Dietary Supplement: Phosphatidylserine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Mar 2023
- Primary completion3 Feb 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded design with 34 subjects
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Martinez-Lemus, DVM, PhD, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557228
- Sponsor's protocol ID
- 2025921
- Acronym
- ADAM17
- Status last verified
- Apr 2026
- First submitted
- 8 Sep 2020
- Last updated
- 4 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting ADAM17 Activity for Correction of Vascular Insulin Resistance in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04557228
- Acronym / sponsor ID
- ADAM17 / 2025921
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- endothelial dysfunction, vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 4 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded design with 34 subjects
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboStudy participants will receive 4 weeks of supplementation with 900mg placebo supplements |
| Phosphatidylserine Supplementation | Experimental | Dietary Supplement: PhosphatidylserineStudy participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke
- History of chronic renal or hepatic disease
- Active cancer
- Autoimmune diseases
- Immunosuppressant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo4 weeks of placebo supplements | Dietary supplement | Placebo |
| Phosphatidylserine4 weeks of phosphatidylserine supplements | Dietary supplement | Phosphatidylserine Supplementation |
Primary outcome
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.
1 secondary outcome
Percent Change in Vascular Function
Time frame: Baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phosphatidylserine in people with Diabetes Mellitus, Type 2, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin-stimulated Blood Flow (time frame: baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.