DAPAgliflozin Sodium Water glucosE EffecTs in Patients at High Cardiovascular Risk

Sponsor
University Health Network, Toronto
Study ID
NCT04258371
Phase
PHASE2
Status
Unknown

Conditions

  • Cardiovascular Risk Factor

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG — DRUG
    Dapagliflozin Tablets Total Dose 10mg daily for 12 weeks
  • Placebo oral tablet — DRUG
    Placebo once daily for 12 weeks

Study Details

This study aims to elucidate the impact of SGLT2 inhibition on peripheral vascular function, renal function, fluid volume, neurohormonal activation and inflammatory/fibrotic pathways in patients with T2D at high cardiovascular risk and non-T2D patients.

Key Dates

Start date
Feb 10, 2020
Status verified
May 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin Treatment Arm
    Dapagliflozin Tablets Total Dose 10mg daily for 12 weeks
  • Placebo Comparator: Placebo Arm
    Placebo Matching Dapagliflozin Tablet for 12 weeks

Primary Outcome Measure

Arterial stiffness [ Time Frame: Acute (1 week) ]

Central Contacts

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