Phase 2
N=14
Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT04867707 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in Glycocalyx Integrity-Perfused Boundary Region — -0.0057 micrometers (mcm)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Zanamivir (Drug)
- Age
- Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycocalyx Integrity-Perfused Boundary Region |
-0.0057 | — |
Summary
The objective is to determine if neuraminidase inhibition with zanamivir is efficacious as a therapeutic strategy to restore endothelial function in T2D patients.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04867707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.