Status:
COMPLETED
Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
45-64 years
Phase:
PHASE2
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....
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04867707
Start Date
July 14 2021
End Date
October 18 2024
Last Update
April 25 2025
Active Locations (1)
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1
University of Missouri, School of Medicine Clinical Research Center
Columbia, Missouri, United States, 65212