ADAM17 and Vascular Function in Diabetes

NCT04557228 | Completed Results DMC

• 1 other identifier: 2025921
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

endothelial dysfunction; vascular function

Outcome Measures

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.

  baseline and 4 weeks

Secondary Outcomes (1)

• Percent Change in Vascular Function

  Baseline and 4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Phosphatidylserine Supplementation

EXPERIMENTAL

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

Dietary Supplement: Phosphatidylserine

Interventions

Placebo DIETARY_SUPPLEMENT

4 weeks of placebo supplements

Placebo

Phosphatidylserine DIETARY_SUPPLEMENT

4 weeks of phosphatidylserine supplements

Phosphatidylserine Supplementation

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri- NextGen Clinical Translational Science Unit

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Phosphatidylserines

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Martinez-Lemus
• Organization: University of Missouri

martinezlemusl@umsystem.edu

573-884-1222

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Medical Pharmacology Physiology

Model Details: Randomized, double-blinded design with 34 subjects

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 21, 2020
• Study Start: March 1, 2023
• Primary Completion: February 3, 2025
• Study Completion: November 1, 2025
• Last Updated: May 4, 2026
• Results First Posted: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)