NCT04557228

ADAM17 and Vascular Function in Diabetes

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 45 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	4 weeks of placebo supplements
DIETARY_SUPPLEMENT	Phosphatidylserine	4 weeks of phosphatidylserine supplements

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-02-03
• Completion: 2025-11-01
• First posted: 2020-09-21
• Last updated: 2025-07-17

Locations

1 site across 1 country: United States