Inhibition of Urinary Angiotensinogen and the Reduction of Blood Pressure by SGLT2 Inhibition in Patients With Type 2 Diabetes

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Tulane University School of Medicine
Study ID
NCT02796170
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    5mg pill taken once daily
  • Placebo — DRUG
    5mg pill taken once daily- placebo of Dapagliflozin

Study Details

To assess the effect of sodium-glucose cotransporter 2 (SGLT-2) inhibitors on blood pressure and urinary angiotensinogen. This is a cross over study design, where 40 subjects will receive Dapagliflozin for 6 weeks followed by placebo for 6 weeks, or placebo for 6 weeks followed by Dapagliflozin for 6 weeks. In addition there will be an arm of 10 subjects who will receive sulfonylurea in an open label as a comparative to the cross over subjects to assess if the effect of Dapagliflozin may also be in part due to improved glycemic control.

Key Dates

Start date
Mar 31, 2016
Status verified
Oct 2022
Primary completion
Aug 31, 2019
Completion
Aug 31, 2020

Study Design

Enrollment
11 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    Participants underwent 6 weeks of Dapagliflozin or placebo (washout period for 2 weeks) and then crossed over to 6 weeks of placebo or Dapagliflozin.
  • Active Comparator: Placebo
    Participants underwent 6 weeks of Dapagliflozin or placebo (washout period for 2 weeks) and then crossed over to 6 weeks of placebo or Dapagliflozin.

Primary Outcome Measure

Change in Blood Pressure From Baseline to 6 Weeks Measured by ABPM [ Time Frame: Baseline to 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tulane UniversityNew OrleansLouisiana70112-

Find similar trials in New Orleans, LA

By condition
Hypertension (high blood pressure)Type 2 diabetes
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Tulane University· New Orleans, LA

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