Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

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

Detailed Description
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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.

Official Title
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Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Zanamivir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with a BMI of 25-39 kg/m2 Ages 45-64 years at randomization. Diagnosis of T2D 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 (Premenopausal women will be required to complete a urine pregnancy test before participation) History of asthma or chronic obstructive pulmonary disease. History of allergic reaction to lactose or milk proteins 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).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group design with 20 subjects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zanamivir treatment<br>Study participants will receive 5 days of treatment with a zanamivir inhaler. | Drug: Zanamivir<br>* 5 days of treatment with 10mg zanamivir inhaler BID<br>* Other names: Relenza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycocalyx integrity | Measure of glycocalyx integrity via Glycocheck. Glycocalyx integrity measures will be performed non-invasively. | 0 and 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vascular function | Flow mediated dilation (FMD) in arm. Brachial artery FMD measures will be performed non-invasively via Ultrasound. | 0 and 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial dysfunction, vascular function, glycocalyx integrity assessment