Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3493
Source ID: NCT05139914
Associated Drug: Dapagliflozin
Title: Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes
Acronym: SFRNDM2
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Endothelial Dysfunction
Interventions: DRUG: Dapagliflozin|OTHER: Placebo
Outcome Measures: Primary: Insulin-mediated endothelial nitric oxide synthase (eNOS) phosphorylation measured in endothelial cells (ECs) at 6 weeks, The percentage change in the phosphorylation of eNOS is measured using quantitative immunofluorescence microscopy in EC collected before and after each treatment period., 6 weeks|Insulin-mediated endothelial nitric oxide synthase (eNOS) phosphorylation measured in endothelial cells (ECs) at 14 weeks, The percentage change in the phosphorylation of eNOS is measured using quantitative immunofluorescence microscopy in EC collected before and after each treatment period., 14 weeks | Secondary: Flow-mediated dilation of the brachial artery at 6 weeks, The percentage change in the diameter of the brachial artery will be measured before and after a 5 minute cuff occlusion on the arm as a measure of endothelial cell (EC) function., 6 weeks|Flow-mediated dilation of the brachial artery at 14 weeks, The percentage change in the diameter of the brachial artery will be measured before and after a 5 minute cuff occlusion on the arm as a measure of endothelial cell (EC) function., 14 weeks|Arterial stiffness at 6 weeks, Arterial stiffness/compliance of the central aorta and upper extremity will be assessed by measuring carotid-femoral and carotid-radial pulse wave velocity (PWV). A small probe is used to record signals from the carotid, radial, and femoral arteries., 6 weeks|Arterial stiffness at 14weeks, Arterial stiffness/compliance of the central aorta and upper extremity will be assessed by measuring carotid-femoral and carotid-radial pulse wave velocity (PWV). A small probe is used to record signals from the carotid, radial, and femoral arteries., 14 weeks|Microvascular dilator function by EndoPAT at 6 weeks, EndoPAT is a noninvasive test to measure the amount of blood flow through the arteries. It determines if the artery is healthy., 6 weeks|Microvascular dilator function by EndoPAT at 14 weeks, EndoPAT is a noninvasive test to measure the amount of blood flow through the arteries. It determines if the artery is healthy., 14 weeks|Plasma non-coding RNA (ncRNA) measurement at 6 weeks, Non-coding RNAs (ncRNAs) levels will be assessed using quantitative polymerase chain reaction (PCR) of RNA isolated from plasma., 6 weeks|Plasma non-coding RNA (ncRNA) measurement at 14 weeks, Non-coding RNAs (ncRNAs) levels will be assessed using quantitative PCR of RNA isolated from plasma., 14 weeks|EC measures of noncoding RNA at 6 weeks, Non-coding RNA levels will be assessed using quantitative PCR of RNA isolated from endothelial cells., 6 weeks|EC measures of noncoding RNA at 14 weeks, Non-coding RNA levels will be assessed using quantitative PCR of RNA isolated from endothelial cells., 14 weeks|EC measures of coding RNA at 6 weeks, RNA levels will be assessed using quantitative PCR of RNA isolated from endothelial cells., 6 weeks|EC measures of coding RNA at 14 weeks, RNA levels will be assessed using quantitative PCR of RNA isolated from endothelial cells., 14 weeks|Circulating brain natriuretic peptide (BNP) biomarkers of vascular health at 6 weeks, A BNP result greater than 100 pg/mL is abnormal., 6 weeks|Circulating brain natriuretic peptide (BNP) biomarkers of vascular health at 14 weeks, A BNP result greater than 100 pg/mL is abnormal., 14 weeks|Circulating C-reactive protein (CRP) biomarkers of vascular health at 6 weeks, Normal CRP is \<10 mg/L. Results 10 or greater are considered abnormal., 6 weeks|Circulating C-reactive protein (CRP) biomarkers of vascular health at 14 weeks, Normal CRP is \<10 mg/L. Results 10 or greater are considered abnormal., 14 weeks
Sponsor/Collaborators: Sponsor: Boston University | Collaborators: American Heart Association
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-05-31
Completion Date: 2025-12
Results First Posted:
Last Update Posted: 2024-12-24
Locations: BU School of Medicine Evans 748, Boston, Massachusetts, 02118, United States
URL: https://clinicaltrials.gov/show/NCT05139914