Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

University of Missouri-Columbia14 enrolled

Overview

The objective is to determine if neuraminidase inhibition with zanamivir is efficacious as a therapeutic strategy to restore endothelial function in T2D patients.

Twenty subjects will complete five days of treatment with zanamivir. Baseline measurements will be taken before the initiation of treatment, as well as after the conclusion of the treatment period (i.e., a total of two assessment visits per subject). Assessment visits will include: vitals (such as blood pressure, heart rate), fasting blood work for plasma neuraminidase activity, plasma sialic acid, plasma glucose and plasma insulin, brachial artery FMD, and glycocalyx integrity assessment via Glycocheck.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

ZanamivirDRUG

5 days of treatment with 10mg zanamivir inhaler BID

Eligibility

Sex: ALLMin age: 45 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Men and women with a BMI of 25-39 kg/m2 2. Ages 45-64 years at randomization. 3. Diagnosis of T2D classified based on physician diagnosis. 4. 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 (Premenopausal women will be required to complete a urine pregnancy test before participation) 10. History of asthma or chronic obstructive pulmonary disease. 11. History of allergic reaction to lactose or milk proteins 12. Intranasal live attenuated influenza vaccine (LAIV) given within 2 weeks before zanamivir administration or a planned dose within 48 hours after zanamivir administration. Product insert states to avoid zanamivir administration with intranasal live attenuated influenza vaccine (LAIV).

Locations (1)

University of Missouri, School of Medicine Clinical Research Center

Columbia, Missouri, United States

Outcomes

Primary Outcomes

Change in Glycocalyx Integrity-Perfused Boundary Region

Glycocalyx integrity will be assessed non-invasively using the GlycoCheck. The Glycocheck video microscope instrument will be placed under the subject's tongue to assess red blood cell penetration of the glycocalyx lining. PBR (perfused boundary region) is a measure of distance (mcm) that red blood cells penetrate into the glycocalyx. An increase in PBR in indicative of lower glycocalyx integrity. Outcomes are reported as a change in PBR from Day 0 to Day 5.

Time frame: Day 0 and Day 5

Data from ClinicalTrials.gov

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