Trial Outcomes & Findings for Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes (NCT NCT04867707)
NCT ID: NCT04867707
Last Updated: 2025-04-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Day 0 and Day 5
Results posted on
2025-04-25
Participant Flow
Participant milestones
| Measure |
Zanamivir Treatment
Study participants will receive 5 days of treatment with a zanamivir inhaler.
Zanamivir: 5 days of treatment with 10mg zanamivir inhaler BID
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Zanamivir Treatment
n=14 Participants
Study participants will receive 5 days of treatment with a zanamivir inhaler.
Zanamivir: 5 days of treatment with 10mg zanamivir inhaler BID
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 5Population: participants that completed full study intervention with baseline and day 5 assessment.
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.
Outcome measures
| Measure |
Zanamivir Treatment
n=14 Participants
Study participants will receive 5 days of treatment with a zanamivir inhaler.
Zanamivir: 5 days of treatment with 10mg zanamivir inhaler BID
|
|---|---|
|
Change in Glycocalyx Integrity-Perfused Boundary Region
|
-0.0057 micrometers (mcm)
Standard Error 0.11
|
Adverse Events
Zanamivir Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zanamivir Treatment
n=14 participants at risk
Study participants will receive 5 days of treatment with a zanamivir inhaler.
Zanamivir: 5 days of treatment with 10mg zanamivir inhaler BID
|
|---|---|
|
General disorders
Changes in mood, sleep, or appetite
|
28.6%
4/14 • Number of events 6 • Baseline assessment (day 0) through Final assessment (Day 5)
Participants were administered a side effects and toxicity questionnaire daily during the dosing period. The questionnaire assessed for common side effects of zanamivir listed in the packaging insert.
|
|
General disorders
Sinus congestion and inflammation
|
0.00%
0/14 • Baseline assessment (day 0) through Final assessment (Day 5)
Participants were administered a side effects and toxicity questionnaire daily during the dosing period. The questionnaire assessed for common side effects of zanamivir listed in the packaging insert.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing, tightness in chest, wheezing, SOB, difficulty breathing
|
7.1%
1/14 • Number of events 2 • Baseline assessment (day 0) through Final assessment (Day 5)
Participants were administered a side effects and toxicity questionnaire daily during the dosing period. The questionnaire assessed for common side effects of zanamivir listed in the packaging insert.
|
|
Musculoskeletal and connective tissue disorders
Joint pain/swelling
|
0.00%
0/14 • Baseline assessment (day 0) through Final assessment (Day 5)
Participants were administered a side effects and toxicity questionnaire daily during the dosing period. The questionnaire assessed for common side effects of zanamivir listed in the packaging insert.
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/14 • Baseline assessment (day 0) through Final assessment (Day 5)
Participants were administered a side effects and toxicity questionnaire daily during the dosing period. The questionnaire assessed for common side effects of zanamivir listed in the packaging insert.
|
|
General disorders
Dizziness
|
0.00%
0/14 • Baseline assessment (day 0) through Final assessment (Day 5)
Participants were administered a side effects and toxicity questionnaire daily during the dosing period. The questionnaire assessed for common side effects of zanamivir listed in the packaging insert.
|
|
General disorders
Fever/Chills
|
0.00%
0/14 • Baseline assessment (day 0) through Final assessment (Day 5)
Participants were administered a side effects and toxicity questionnaire daily during the dosing period. The questionnaire assessed for common side effects of zanamivir listed in the packaging insert.
|
|
Psychiatric disorders
Hallucinations or delusions
|
0.00%
0/14 • Baseline assessment (day 0) through Final assessment (Day 5)
Participants were administered a side effects and toxicity questionnaire daily during the dosing period. The questionnaire assessed for common side effects of zanamivir listed in the packaging insert.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place