Role of Canagliflozin on CD34+ Cells in Patients With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT02964585|
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : July 23, 2020
The investigators hypothesize that Cana may be able to improve number and function of CD34+ endothelial progenitor cells. The investigators also propose that this expected cardiovascular benefit is independent of HbA1C reduction.
Subjects will begin taking 100 mg of Cana or placebo after initial 4 weeks. Subjects will be withdrawn from the study if the medication or placebo is not tolerated.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: Canagliflozin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Role of Canagliflozin on Gene Expression and Function of CD34+ Endothelial Progenitor Cells and Renal Function in Patients With Type 2 Diabetes|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||September 2020|
Active Comparator: Active Arm
100 mg of Canagliflozin for 16 weeks
Other Name: INVOKANA
Placebo Comparator: Placebo Arm
Placebo for 16 weeks
1 tablet daily for 16 weeks
- Gene Expression and Function change of CD34+ Endothelial Progenitor Cells [ Time Frame: Up to 12 weeks post Canagliflozin treatment ]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.
- Serum Endothelial Inflammatory Markers [ Time Frame: Up to 8 and 16 weeks post Canagliflozin treatment ]Highly selective C-reactive protein (hs-CRP), IL-6, and TNF-alpha
- Fasting Lipid Profile [ Time Frame: Up to 8 and 16 weeks post Canagliflozin treatment ]Measured from a serum blood Lipid Panel
- Glycemic Control [ Time Frame: Up to 8 and 16 weeks post Canagliflozin treatment ]Measured from blood glucose and HbA1C values
- Creatinine Clearance [ Time Frame: Up to 8 and 16 weeks post Canagliflozin treatment ]Measured from compiled results from a urine sample and blood tests
- Adiposity [ Time Frame: Up to 8 and 16 weeks post Canagliflozin treatment ]Measured using a body composition scale
- Resting Metabolic Rate (RMR) [ Time Frame: Up to 8 and 16 weeks post Canagliflozin treatment ]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 .
- Vessel Health [ Time Frame: Up to 8 and 16 weeks post Canagliflozin treatment ]Vessel health will be assessed by using arterial tonometry with the SphygmoCor CP system from ATCOR .
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): NCT02964585
|Contact: Hassan Awalfirstname.lastname@example.org|
|United States, District of Columbia|
|The George Washington University Medical Faculty Associates||Recruiting|
|Washington, District of Columbia, United States, 20037|
|Contact: Hassan Awal 202-741-2389 email@example.com|
|Principal Investigator:||Sabyasachi Sen, MD, PhD||Medical Faculty Associates|