Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-14

Study Completion Date

2024-10-18

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group design with 20 subjects

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zanamivir treatment

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

Group Type EXPERIMENTAL

Zanamivir

Intervention Type DRUG

5 days of treatment with 10mg zanamivir inhaler BID

Interventions

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Zanamivir

5 days of treatment with 10mg zanamivir inhaler BID

Intervention Type DRUG

Other Intervention Names

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Relenza

Eligibility Criteria

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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).

Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No