Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes

Who is this study for? Patients with type 2 diabetes
What treatments are being studied? Dapagliflozin
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Patients with Type 2 Diabetes Mellitus (T2DM) have changes in blood vessel health that can lead to a higher chance of developing heart attacks or strokes. New medications for T2DM including dapagliflozin, which is a Sodium-Glucose Cotransporter-2 inhibitor (SGLT2) inhibitor, may help protect the heart and blood vessels. The overarching objective of this mechanistic study is to learn how a Sodium-Glucose Cotransporter-2 (SGT2) inhibitor, dapagliflozin, impacts vascular health in patients with Type 2 Diabetes Mellitus (T2DM). The investigators will compare the changes in vascular health to changes in endothelial cell (EC) phenotype including non-coding RNA (ncRNA) to develop evidence supporting the mechanism of cardiovascular benefit of SGLT2 inhibitors. This study will provide novel information regarding the mechanism of effects of novel treatments for endothelial function and vascular health in patients with T2DM to reduce cardiovascular (CV) risk. The research aims to assess the: * effects of dapagliflozin on EC phenotype. * impact of dapagliflozin on vasodilator function and additional measures of vascular health including arterial stiffness and circulating markers of vascular health.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• Diagnosis of T2DM for minimum of 3 months defined as fasting glucose greater than or equal to 120 mg/dL, hemoglobin A1C (HbA1C) ≥6.5%

• Body mass index (BMI) \>25

• Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.

Locations
United States
Massachusetts
BU School of Medicine Evans 748
RECRUITING
Boston
Contact Information
Primary
Naomi Hamburg, MD
nhamburg@bu.edu
(617) 638-7260
Time Frame
Start Date: 2022-05-31
Estimated Completion Date: 2025-12
Participants
Target number of participants: 50
Treatments
Experimental: Dapagliflozin then Placebo
Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between.
Placebo_comparator: Placebo then dapagliflozin
Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between.
Sponsors
Leads: Boston University
Collaborators: American Heart Association

This content was sourced from clinicaltrials.gov