An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin

Part of paid clinical trials in Buffalo, New York.

Sponsor
University at Buffalo
Study ID
NCT02433678
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • dapagliflozin — DRUG
    SGLT-2 inhibitor for the treatment of type 2 diabetes
  • Placebo — DRUG

Study Details

This is a single center, prospective, randomized, placebo -controlled, parallel design and double blind study to evaluate oxidative stress, inflammation and hypertension markers and mediators before and after treatment with dapagliflozin.

Key Dates

First listed
May 5, 2015
Start date
Nov 30, 2015
Status verified
Oct 2019
Primary completion
Mar 31, 2018
Completion
Nov 30, 2018

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Patients will be treated for 12 weeks with placebo once daily
  • Active Comparator: Dapagliflozin
    10 mg daily for the 12 weeks

Primary Outcome Measure

Difference in the Percent Change in Fasting Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Activation (DNA Binding Activity) in Mononuclear Cells Before and After Dapagliflozin Use [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
ECMC Ambulatory Center, 3rd FloorBuffaloNew York14215-

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By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
ECMC Ambulatory Center, 3rd Floor· Buffalo, NY

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