ADAM17 and Vascular Function in Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— ADAM17  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04557228
• Other study ID #: 2025921
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: Luis Martinez-Lemus, PhD
• Phone: (573) 882-3244
• Email: martinezlemusl[@]missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

As part of a randomized (2:1, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: November 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Placebo
4 weeks of placebo supplements
• Phosphatidylserine
4 weeks of phosphatidylserine supplements

Locations

Country	Name	City	State
United States	University of Missouri- NextGen Clinical Translational Science Unit	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and 4 weeks