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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Zanamivir

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring endothelial dysfunction, vascular function, glycocalyx integrity assessment

Eligibility Criteria

45 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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).

Sites / Locations

University of Missouri, School of Medicine Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zanamivir treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Change in glycocalyx integrity

Measure of glycocalyx integrity via Glycocheck. Glycocalyx integrity measures will be performed non-invasively.

Secondary Outcome Measures

Change in Vascular function

Flow mediated dilation (FMD) in arm. Brachial artery FMD measures will be performed non-invasively via Ultrasound.

Full Information

NCT ID

NCT04867707

First Posted

April 27, 2021

Last Updated

July 3, 2023

Sponsor

University of Missouri-Columbia

1. Study Identification

Unique Protocol Identification Number

NCT04867707

Brief Title

Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

Acronym

NAED

Official Title

Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 14, 2021 (Actual)

Primary Completion Date

April 13, 2025 (Anticipated)

Study Completion Date

April 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

endothelial dysfunction, vascular function, glycocalyx integrity assessment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Single group design with 20 subjects

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zanamivir treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Zanamivir

Other Intervention Name(s)

Relenza

Intervention Description

5 days of treatment with 10mg zanamivir inhaler BID

Primary Outcome Measure Information:

Title

Change in glycocalyx integrity

Description

Measure of glycocalyx integrity via Glycocheck. Glycocalyx integrity measures will be performed non-invasively.

Time Frame

0 and 5 days

Secondary Outcome Measure Information:

Title

Change in Vascular function

Description

Flow mediated dilation (FMD) in arm. Brachial artery FMD measures will be performed non-invasively via Ultrasound.

Time Frame

0 and 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis Martinez-Lemus, PhD

Organizational Affiliation

University of Missouri, School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Missouri, School of Medicine Clinical Research Center

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

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