Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective is to determine if neuraminidase inhibition with zanamivir is efficacious as a therapeutic strategy to restore endothelial function in T2D patients.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanamivir treatment | Experimental | Study participants will receive 5 days of treatment with a zanamivir inhaler. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanamivir | Drug | 5 days of treatment with 10mg zanamivir inhaler BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luis Martinez-Lemus, PhD | University of Missouri, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri, School of Medicine Clinical Research Center | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37801046 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zanamivir Treatment | Study participants will receive 5 days of treatment with a zanamivir inhaler. Zanamivir: 5 days of treatment with 10mg zanamivir inhaler BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zanamivir Treatment | Study participants will receive 5 days of treatment with a zanamivir inhaler. Zanamivir: 5 days of treatment with 10mg zanamivir inhaler BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | participants that completed full study intervention with baseline and day 5 assessment. | Posted | Mean | Standard Error | micrometers (mcm) | Day 0 and Day 5 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zanamivir Treatment | Study participants will receive 5 days of treatment with a zanamivir inhaler. Zanamivir: 5 days of treatment with 10mg zanamivir inhaler BID |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Changes in mood, sleep, or appetite | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Luis Martinez | University of Missouri | (573) 882-3244. | martinezlemusl@umsystem.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2022 | Jan 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2022 | Jan 9, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D053243 | Zanamivir |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D012794 | Sialic Acids |
Not provided
Not provided
Single group design with 20 subjects
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 4 |
| 14 |
| Sinus congestion and inflammation | General disorders | Systematic Assessment |
|
| Coughing, tightness in chest, wheezing, SOB, difficulty breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Joint pain/swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Allergic Reaction | Immune system disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Fever/Chills | General disorders | Systematic Assessment |
|
| Hallucinations or delusions | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D009438 |
| Neuraminic Acids |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |