Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7183
Source ID: NCT02024477
Associated Drug: Saxagliptin
Title: Effect of Saxagliptin on EPCs as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early T2DM Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02024477/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Placebo
Outcome Measures: Primary: CD34+ Endothelial Progenitor Cells Number, We will use patient's peripheral blood derived CD34+ cells looking at number of CD34+ Endothelial Progenitor Cell as % of the total Mononuclear cell population. Post saxagliptin will be compared to pre saxagliptin measurement, Up to 12 weeks post saxagliptin|CD 34+ Cell Function, function of EPC cell as migration of CD34+ cells in response to SDF-1a ( 100 ng/mL). Results are expressed in fluorescence ratio between cells exposed to the chemotactic factor and cells exposed to chemo attractant-free media ( control) followed by lysis in presence of CyQuant GR dye., Up to 12 weeks post saxagliptin Up to 12 weeks post saxagliptin: Visit 1 at Baseline, Visit 2 at 6 weeks, and Visit 3 at 12 weeks | Secondary: Serum Endothelial Inflammatory Marker hsCRP, Baseline 6 and 12 weeks post saxagliptin|Fasting Lipid Profile LDL/HDL, ratio of LDL over HDL, Baseline, 6 and 12 weeks post saxagliptin|Glycemic Control, measuring HbA1c levels, Baseline, 6 and 12 weeks post saxagliptin|Adiposity, measured using a Tanita Body Composition Fat Analyzer scale, measured as percentage body fat, Baseline, 6 and 12 weeks post saxagliptin|Arterial Stiffness, Arterial stiffness assessed using Vascular Flow and wave measurement equipment, SphygmoCor CP system from ATCOR. Reported as Augmentation Index adjusted for a heart rate of 75. Augmentation index (AIx) is a measure of systemic arterial stiffness derived from the ascending aortic pressure waveform. Lower the value, better correlated outcome as positive augmentation represents stiffer artery., Baseline, 6 and 12 weeks post saxagliptin
Sponsor/Collaborators: Sponsor: George Washington University | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 42
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-11
Completion Date: 2017-12
Results First Posted: 2019-01-29
Last Update Posted: 2019-02-15
Locations: Medical Faculty Associates Inc, Washington, District of Columbia, 20037, United States
URL: https://clinicaltrials.gov/show/NCT02024477