Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes

NCT04867707 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2038203
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

endothelial dysfunction; vascular function; glycocalyx integrity assessment

Outcome Measures

Primary Outcomes (1)

• Change in Glycocalyx Integrity-Perfused Boundary Region

  Glycocalyx integrity will be assessed non-invasively using the GlycoCheck. The Glycocheck video microscope instrument will be placed under the subject's tongue to assess red blood cell penetration of the glycocalyx lining. PBR (perfused boundary region) is a measure of distance (mcm) that red blood cells penetrate into the glycocalyx. An increase in PBR in indicative of lower glycocalyx integrity. Outcomes are reported as a change in PBR from Day 0 to Day 5.

  Day 0 and Day 5

Study Arms (1)

Zanamivir treatment

EXPERIMENTAL

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

Drug: Zanamivir

Interventions

Zanamivir DRUG

5 days of treatment with 10mg zanamivir inhaler BID

Also known as: Relenza

Zanamivir treatment

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri, School of Medicine Clinical Research Center

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

• Foote CA, Ramirez-Perez FI, Smith JA, Ghiarone T, Morales-Quinones M, McMillan NJ, Augenreich MA, Power G, Burr K, Aroor AR, Bender SB, Manrique-Acevedo C, Padilla J, Martinez-Lemus LA. Neuraminidase inhibition improves endothelial function in diabetic mice. Am J Physiol Heart Circ Physiol. 2023 Dec 1;325(6):H1337-H1353. doi: 10.1152/ajpheart.00337.2023. Epub 2023 Oct 6.

  PMID: 37801046 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Zanamivir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Sialic Acids; Neuraminic Acids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amino Sugars; Carbohydrates

Results Point of Contact

• Title: Dr. Luis Martinez
• Organization: University of Missouri

martinezlemusl@umsystem.edu

(573) 882-3244.

Study Officials

• Luis Martinez-Lemus, PhD

  University of Missouri, School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Medical Pharmacology Physiology

Model Details: Single group design with 20 subjects

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: July 14, 2021
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: April 25, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)