ADAM17 and Vascular Function in Diabetes

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Phosphatidylserine; Dietary Supplement: Placebo

• Registration Number: NCT04557228
• Lead Sponsor: University of Missouri-Columbia

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.

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 Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Study Start: 2023-03-01
• Status Verified: 2025-02
• Primary Completion: 2025-02-03
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phosphatidylserine Supplementation	Phosphatidylserine	Study participants will receive 4 weeks of supplementation with 900mg phosphatidylserine supplements.
Placebo	Placebo	Study participants will receive 4 weeks of supplementation with 900mg placebo supplements

Primary Outcome Measures

Name	Time	Method
Change in Insulin-stimulated blood flow	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 Outcome Measures

Name	Time	Method
Change in Vascular function	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.

Trial Locations

Locations (1)

University of Missouri- NextGen Clinical Translational Science Unit; 🇺🇸 Columbia, Missouri, United States