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Clinical Trial Details

Trial ID: L5626
Source ID: NCT02964585
Associated Drug: Canagliflozin
Title: Role of Canagliflozin on CD34+ Cells in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02964585/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Canagliflozin|DRUG: Placebo
Outcome Measures: Primary: Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression), To determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before \[13,14\]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis., 16 weeks post Canagliflozin treatment reported|Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Percentages), To determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before \[13,14\]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis., 16 weeks post Canagliflozin treatment reported|Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Counts), To determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before \[13,14\]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis., 16 weeks post Canagliflozin treatment reported|Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Proliferation), To determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before \[13,14\]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis., 16 weeks post Canagliflozin treatment reported | Secondary: Serum Endothelial Inflammatory Markers (1), IL-6, and TNF-alpha, measured at 8 and 16 (reported) weeks post treatment|Fasting Lipid Profile, Measured from a serum blood Lipid Panel: cholesterol and serum ketone bodies, 16 weeks post Canagliflozin treatment reported (also measured at 8 weeks)|Glycemic Control (HbA1C), As determined by HbA1C values, 16 weeks post Canagliflozin treatment reported|BMI, Determined as weight in kg divided by height in meters squared, 16 weeks post Canagliflozin treatment|Resting Metabolic Rate (RMR), Using ReeVue (trademark) machine, with or without SGLT2 inhibitor therapy to ascertain if Cana has any effect on RMR. Other related trials have shown weight loss but effect on metabolic rate has not been studied ., 16 weeks post Canagliflozin treatment|Pulse Wave Velocity, Vessel health assessed by using arterial tonometry with the SphygmoCor CP system from ATCOR ., 16 weeks post Canagliflozin treatment reported (also measured at 8 weeks)|Serum Endothelial Inflammatory Markers (2), Highly selective C-reactive protein (hs-CRP), measured at 8 and 16 (reported) weeks post treatment|Glycemic Control, Measured from blood glucose values (fasting) during visit, 16 weeks post Canagliflozin treatment reported|Body Fat Percentage, Measured using a Tanita body composition scale, 16 weeks post Canagliflozin treatment|Augmentation Index (Pulse Wave Analysis), Vessel health assessed by using arterial tonometry with the SphygmoCor CP system from ATCOR. Higher values generally correlate with increased cardiovascular risk., 16 weeks post Canagliflozin treatment reported (also measured at 8 weeks)|Kidney Function Markers, Creatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests, 16 weeks post Canagliflozin treatment reported|Creatinine (Urine), Creatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests, 16 weeks post Canagliflozin treatment reported|Microalbumin, Creatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests, 16 weeks post Canagliflozin treatment reported|eGFR, Creatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests, 16 weeks post Canagliflozin treatment reported
Sponsor/Collaborators: Sponsor: George Washington University | Collaborators: Janssen Scientific Affairs, LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 34
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-11
Completion Date: 2020-09
Results First Posted: 2022-12-07
Last Update Posted: 2022-12-07
Locations: The George Washington University Medical Faculty Associates, Washington, District of Columbia, 20037, United States
URL: https://clinicaltrials.gov/show/NCT02964585