ADAM17 and Vascular Function in Diabetes

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04557228

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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, improves vascular function and insulin-stimulated leg blood flow in subjects with type 2 diabetes (T2D).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Dietary Supplement: Placebo Dietary Supplement: Phosphatidylserine	N/A

Detailed Description

As part of a randomized, double-blinded crossover design, each of the 34 subjects will complete 4 weeks of supplementation with 400mg of PS and 4 weeks of placebo. Subjects will have a 4-week washout period between regimens. Assessment visits (2) will occur after each of the 4-week dosing schemes and include: Vitals, DEXA scan for body composition, fasting blood work, brachial artery flow-mediated dilation (FMD) with near infrared spectroscopy (NIRS), skeletal muscle biopsy, glycocalyx integrity assessment via Glycocheck, and 1-hour insulin clamp procedure with blood flow measurements.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized, double-blinded crossover design with 34 subjectsRandomized, double-blinded crossover design with 34 subjects

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Study participants will receive 4 weeks of supplementation with 400mg placebo supplements	Dietary Supplement: Placebo 4 weeks of placebo supplements
Experimental: Phosphatidylserine Supplementation Study participants will receive 4 weeks of supplementation with 400mg phosphatidylserine supplements.	Dietary Supplement: Phosphatidylserine 4 weeks of 400mg phosphatidylserine supplements

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Study participants will receive 4 weeks of supplementation with 400mg placebo supplements

Dietary Supplement: Placebo

4 weeks of placebo supplements

Experimental: Phosphatidylserine Supplementation

Study participants will receive 4 weeks of supplementation with 400mg phosphatidylserine supplements.

Dietary Supplement: Phosphatidylserine

4 weeks of 400mg phosphatidylserine supplements

Outcome Measures

Primary Outcome Measures

Change in Insulin-stimulated blood flow [week 4 and week 12]
Measure of blood flow during insulin clamp. Leg blood flow measures will be performed non-invasively via Ultrasound.

Secondary Outcome Measures

Change in Vascular function [week 4 and week 12]
Flow mediated dilation (FMD) in arm. Brachial artery FMD measures will be performed non-invasively via Ultrasound.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri- Dalton Cardiovascular Research Center	Columbia	Missouri	United States	65211

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luis Martinez-Lemus, DVM, PhD, Professor in Medical Pharmacology Physiology, University of Missouri-Columbia

ClinicalTrials.gov Identifier:

NCT04557228

Other Study ID Numbers:

2025921

First Posted:

Sep 21, 2020

Last Update Posted:

Apr 21, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Luis Martinez-Lemus, DVM, PhD, Professor in Medical Pharmacology Physiology, University of Missouri-Columbia

endothelial dysfunction

insulin-stimulated blood flow

vascular function

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 21, 2022