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OpenTrials
Completed

NCT Number: NCT04867707

Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

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

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Key information

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Missouri, School of Medicine Clinical Research Center

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Zanamivir

Drug

5 days of treatment with 10mg zanamivir inhaler BID

Other names: Relenza

Primary outcomes

  1. Change in Glycocalyx Integrity-Perfused Boundary Region

    Time frame: Day 0 and Day 5

    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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Acronym: NAED

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2021
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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