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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University
Study ID
NCT05139914
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    10 mg/day (in capsule form) of dapagliflozin for 6 weeks
  • Placebo — OTHER
    Placebo capsule for 6 weeks

Study Details

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.

Key Dates

Start date
May 31, 2022
Status verified
Jan 2026
Primary completion
Feb 4, 2025
Completion
Feb 4, 2025

Study Design

Enrollment
4 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Mean Systolic Blood Pressure [ Time Frame: 14 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
BU School of Medicine Evans 748BostonMassachusetts02118-

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Find similar trials in Boston, MA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
BU School of Medicine Evans 748· Boston, MA

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