Diabetes Mellitus, Type 2Phase 2NAEDNCT04867707
Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes
A Phase 2 study testing Zanamivir in people with Diabetes Mellitus, Type 2, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Zanamivir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2021to 18 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri, School of Medicine Clinical Research Center
Columbia, Missouri, 65212
About this study
The objective is to determine if neuraminidase inhibition with zanamivir is efficacious as a therapeutic strategy to restore endothelial function in T2D patients.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Zanamivir
- Keywords
- endothelial dysfunction, vascular function, glycocalyx integrity assessment
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanamivirDrug
Also called Relenza
5 days of treatment with 10mg zanamivir inhaler BID
| Study group | Role | What they receive |
|---|---|---|
| Zanamivir treatment | Experimental | Study participants will receive 5 days of treatment with a zanamivir inhaler. Receives: Drug: Zanamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start14 Jul 2021
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group design with 20 subjects
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Martinez-Lemus, DVM, PhD, University of Missouri-Columbia
- Investigators
- Luis Martinez-Lemus, PhD, Principal investigator, University of Missouri, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867707
- Sponsor's protocol ID
- 2038203
- Acronym
- NAED
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2021
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37801046
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04867707
- Acronym / sponsor ID
- NAED / 2038203
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- endothelial dysfunction, vascular function, glycocalyx integrity assessment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group design with 20 subjects
| Arm | Type | Receives |
|---|---|---|
| Zanamivir treatment | Experimental | Drug: ZanamivirStudy participants will receive 5 days of treatment with a zanamivir inhaler. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke
- History of chronic renal or hepatic disease
- Active cancer
- Autoimmune diseases
- Immunosuppressant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanamivirAlso: Relenza5 days of treatment with 10mg zanamivir inhaler BID | Drug | Zanamivir treatment |
Primary outcome
Change in Glycocalyx Integrity-Perfused Boundary Region
Time frame: Day 0 and Day 5
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37801046Foote 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.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Martinez-Lemus, PhD principal investigator
University of Missouri, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanamivir in people with Diabetes Mellitus, Type 2, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycocalyx Integrity-Perfused Boundary Region (time frame: Day 0 and Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04867707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.