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Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes (NAED)

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ClinicalTrials.gov Identifier: NCT04867707
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : June 7, 2022
Information provided by (Responsible Party):
Luis Martinez-Lemus, DVM, PhD, University of Missouri-Columbia

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Zanamivir Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group design with 20 subjects
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : April 13, 2025
Estimated Study Completion Date : April 13, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Zanamivir

Arm Intervention/treatment
Experimental: Zanamivir treatment
Study participants will receive 5 days of treatment with a zanamivir inhaler.
Drug: Zanamivir
5 days of treatment with 10mg zanamivir inhaler BID
Other Name: Relenza

Primary Outcome Measures :
  1. Change in glycocalyx integrity [ Time Frame: 0 and 5 days ]
    Measure of glycocalyx integrity via Glycocheck. Glycocalyx integrity measures will be performed non-invasively.

Secondary Outcome Measures :
  1. Change in Vascular function [ Time Frame: 0 and 5 days ]
    Flow mediated dilation (FMD) in arm. Brachial artery FMD measures will be performed non-invasively via Ultrasound.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867707

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Contact: Luis Martinez-Lemus, PhD (573) 882-3244 martinezlemusl@missouri.edu
Contact: Jaume Padilla, PhD (573) 882-7056 padillaja@missouri.edu

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United States, Missouri
University of Missouri, School of Medicine Clinical Research Center Recruiting
Columbia, Missouri, United States, 65212
Contact: Katherine Burr, MS    573-884-1222    katherineburr@health.missouri.edu   
Contact: Andrea Atkins, BSN    (573) 882-8591    wiesa@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
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Principal Investigator: Luis Martinez-Lemus, PhD University of Missouri, School of Medicine
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Responsible Party: Luis Martinez-Lemus, DVM, PhD, Professor in Medical Pharmacology Physiology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04867707    
Other Study ID Numbers: 2038203
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Luis Martinez-Lemus, DVM, PhD, University of Missouri-Columbia:
endothelial dysfunction
vascular function
glycocalyx integrity assessment
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action