Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes (NAED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04867707|
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : June 7, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Zanamivir||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group design with 20 subjects|
|Masking:||None (Open Label)|
|Official Title:||Role of Neuraminidase Activity on Endothelial Dysfunction in Type 2 Diabetes|
|Actual Study Start Date :||July 14, 2021|
|Estimated Primary Completion Date :||April 13, 2025|
|Estimated Study Completion Date :||April 13, 2025|
Experimental: Zanamivir treatment
Study participants will receive 5 days of treatment with a zanamivir inhaler.
5 days of treatment with 10mg zanamivir inhaler BID
Other Name: Relenza
- Change in glycocalyx integrity [ Time Frame: 0 and 5 days ]Measure of glycocalyx integrity via Glycocheck. Glycocalyx integrity measures will be performed non-invasively.
- Change in Vascular function [ Time Frame: 0 and 5 days ]Flow mediated dilation (FMD) in arm. Brachial artery FMD measures will be performed non-invasively via Ultrasound.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||45 Years to 64 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04867707
|Contact: Luis Martinez-Lemus, PhD||(573) email@example.com|
|Contact: Jaume Padilla, PhD||(573) firstname.lastname@example.org|
|United States, Missouri|
|University of Missouri, School of Medicine Clinical Research Center||Recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: Katherine Burr, MS 573-884-1222 email@example.com|
|Contact: Andrea Atkins, BSN (573) 882-8591 firstname.lastname@example.org|
|Principal Investigator:||Luis Martinez-Lemus, PhD||University of Missouri, School of Medicine|
|Responsible Party:||Luis Martinez-Lemus, DVM, PhD, Professor in Medical Pharmacology Physiology, University of Missouri-Columbia|
|Other Study ID Numbers:||
|First Posted:||April 30, 2021 Key Record Dates|
|Last Update Posted:||June 7, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
glycocalyx integrity assessment
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action