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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04867707
Other study ID # 2038203
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 14, 2021
Est. completion date April 13, 2025

Study information

Verified date July 2023
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 14
Est. completion date April 13, 2025
Est. primary completion date April 13, 2025
Accepts healthy volunteers No
Gender All
Age group 45 Years to 64 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Zanamivir
5 days of treatment with 10mg zanamivir inhaler BID

Locations

Country Name City State
United States University of Missouri, School of Medicine Clinical Research Center Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in glycocalyx integrity Measure of glycocalyx integrity via Glycocheck. Glycocalyx integrity measures will be performed non-invasively. 0 and 5 days
Secondary Change in Vascular function Flow mediated dilation (FMD) in arm. Brachial artery FMD measures will be performed non-invasively via Ultrasound. 0 and 5 days
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