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Clinical Trial Details

Trial ID: L6447
Source ID: NCT03660683
Associated Drug: Dapagliflozin 10mg
Title: Effect of Saxagliptin and Dapagliflozin on Endothelial Progenitor Cell in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03660683/results
Conditions: Diabetes Mellitus, Type 2|Cardiovascular Diseases
Interventions: DRUG: Dapagliflozin 10mg|DRUG: Saxagliptin 5mg|DRUG: Placebo Oral Tablet
Outcome Measures: Primary: CD 34+ Cell Migratory Function, Proportion of cells that migrate through SDF1a in a transwell assay. This proportion is represented as a migratory rating scale from 0-1, with 1 being 100% of cells migrate. A larger value indicates better migratory function of the CD34+ cells., 16 weeks | Secondary: CD 34+ Cell Gene Expression, Fold change of Gene Expression in T2Dm with CVD relative to visit 1, 16 weeks from visit 1|CD 34+ Cell Fraction, Quantifying CD34+ cells is based on proportion of the monocytes that are CD34+ to account for any variations in cell harvesting or death during analysis., 16 weeks|Arterial Stiffness - Augmentation Index, Augmentation index was calculated via tonometry with Sphygmocor Device (Pulse Wave Analysis). Augmentation index is calculated as the augmentation pressure (the amplitude of the reflected pulse wave) divided by the pulse pressure (systolic - diastolic) \* 100 to give a percentage of pulse pressure. The software then calculates an estimated Augmentation Index at heart rate of 75 as a form of "normalization." Lower values are generally preferred as they indicate more pliable and healthy arteries., 16 Weeks|Blood Biochemistries, hsCRP, 16 Weeks|Renal Function, Microalbumin/Creatinine Ratio (Proteinuria), 16 Weeks|Urine Exosome Assay, Protein western analysis of Exosomes released from Kidney Podocyte is a indicator of kidney Podocyte health. Expressed as a ratio normalized to CD9 expression, 16 Weeks|Arterial Stiffness, Pulse Wave Velocity, Week 16|Arterial Stiffness - Augmentation Pressure, Augmentation index was calculated via tonometry with Sphygmocor Device (Pulse Wave Analysis). Augmentation index is calculated as the augmentation pressure (the amplitude of the reflected pulse wave) divided by the pulse pressure (systolic - diastolic) \* 100 to give a percentage of pulse pressure. The software then calculates an estimated Augmentation Index at heart rate of 75 as a form of "normalization." Lower values are generally preferred as they indicate more pliable and healthy arteries. Here, augmentation pressure is shown as a reference for the Augmentation Index calculations in the previous section., 16 Weeks | Other: Fasting Lipid Profile, Total Cholesterol, LDL, HDL and VLDL, 16 Weeks|Serum Insulin Level, Measured in fasting state at visit, 16 Weeks|Serum Glucose, Fasting Glucose level measured in serum, 16 Weeks|Appetite Controlling Hormone, Leptin, (Adiponectin, GLP1, Ghrelin in separate entry), 16 Weeks|Serum Glucose, HbA1C (estimate of serum glucose over 3 months), 16 Weeks
Sponsor/Collaborators: Sponsor: Sabyasachi Sen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 15
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-10-22
Completion Date: 2021-12-10
Results First Posted: 2023-06-05
Last Update Posted: 2023-06-05
Locations: The GW Medical Faculty Associates, Washington, District of Columbia, 20037, United States
URL: https://clinicaltrials.gov/show/NCT03660683