| Trial ID: | L7074 |
| Source ID: | NCT05205005
|
| Associated Drug: |
Endocalyx
|
| Title: |
Targeting the Endothelial Glycocalyx to Enhance Vascular Function and Exercise-Induced Vascular Adaptations in Type 2 Diabetes
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT05205005/results
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| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Endocalyx|DRUG: Placebo
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| Outcome Measures: |
Primary: Glygocalyx 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., Change from baseline to eight weeks assessment | Secondary: Brachial Artery Flow Mediated Dilation, Arterial measurements will be performed by imaging the brachial artery artery longitudinally using high-resolution duplex ultrasonography. Arterial vasodilatory responses to hyperemia (flow-mediated dilation; FMD) will be examined by inflating a cuff up to 250 mmHg for five minutes. Before, during and after rapid release of the cuff, brachial artery blood flow velocity and diameter will be continuously measured. This is a measurement of endothelial function. When assessing FMD, the blood pressure cuff will squeeze the arm tightly; however, any discomfort will be alleviated as soon as the pressure in the cuff is released., Change from baseline to eight weeks assessment|Insulin-stimulated Leg Blood Flow, Insulin-stimulated leg blood flow will be assessed via Doppler and contrast-enhanced ultrasound during a three-hour hyperinsulinemic-euglycemic clamp. After a minimum of 20 minutes in supine rest, baseline cardiovascular measurements will be collected, including Doppler and contrast-enhanced ultrasound-based measures, blood samples obtained and then the insulin clamp will start. Briefly, insulin (Humulin R U-100) will be infused via IV at a constant rate of 80mU/m2 body surface area/min for the three-hour period. Blood glucose will be measured at five-minute intervals and maintained at fasting levels; this will be achieved by variable IV infusion rates of a 20% dextrose solution. The measurements described will allow for the assessment of the insulin stimulated leg blood flow, Change from baseline to eight weeks assessment|Popliteal Artery Flow Mediated Dilation, Arterial measurements will be performed by imaging the popliteaL artery longitudinally using high-resolution duplex ultrasonography. Arterial vasodilatory responses to hyperemia (flow-mediated dilation; FMD) will be examined by inflating a cuff up to 250 mmHg for five minutes. Before, during and after rapid release of the cuff, popliteal artery blood flow velocity and diameter will be continuously measured (these are used to calculate the FMD). This is a measurement of endothelial function. When assessing FMD, the blood pressure cuff will squeeze the leg tightly; however, any discomfort will be alleviated as soon as the pressure in the cuff is released., Change from baseline to eight weeks assessment
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| Sponsor/Collaborators: |
Sponsor: VA Office of Research and Development
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| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
PHASE2|PHASE3
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| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2022-05-25
|
| Completion Date: |
2024-07-31
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| Results First Posted: |
2025-04-02
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| Last Update Posted: |
2025-04-02
|
| Locations: |
Harry S. Truman Memorial, Columbia, MO, Columbia, Missouri, 65201-5275, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05205005
|
