Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— NAED  

Official title:

Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04867707
• Other study ID #: 2038203
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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