Overview

Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

Status:
Recruiting
Trial end date:
2025-05-01
Target enrollment:
0
Participant gender:
All
Summary
The objective is to determine if neuraminidase inhibition with zanamivir is efficacious as a therapeutic strategy to restore endothelial function in T2D patients.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Missouri-Columbia
Treatments:
Zanamivir
Criteria
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).