Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes (NAED)

University of Missouri (MU)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Zanamivir

Study type: Interventional

Funder types: Other

Identifiers

NCT04867707

2038203

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 45 to 64 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Zanamivir treatment

Experimental group

Description:

Study participants will receive 5 days of treatment with a zanamivir inhaler.

Treatment:

Drug: Zanamivir