Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Zanamivir

• Registration Number: NCT04867707
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-30
• Study Start: 2021-07-14
• Primary Completion: 2024-10-18
• Study Completion: 2024-10-18
• Status Verified: 2025-04
• Results First Submitted: 2025-04-01
• Results First Submitted QC: 2025-04-01
• Results First Posted: 2025-04-18
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zanamivir treatment	Zanamivir	Study participants will receive 5 days of treatment with a zanamivir inhaler.

Primary Outcome Measures

Name	Time	Method
Change in Glycocalyx Integrity-Perfused Boundary Region	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.

Trial Locations

Locations (1)

University of Missouri, School of Medicine Clinical Research Center; 🇺🇸 Columbia, Missouri, United States