Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension

Sponsor
University of Guadalajara
Study ID
NCT03006471
Phase
PHASE4
Status
Completed

Conditions

  • PreDiabetes
  • Prehypertension

Eligibility Criteria

Sex
ALL
Age
30 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    10 mg, one per day before breakfast during 12 weeks.
  • Placebo - Cap — DRUG
    one per day before breakfast during 12 weeks.

Study Details

Prediabetes is defined as an intermediate metabolic state that leads to the development of type 2 diabetes mellitus (DM2) and the prehypertension is a category assigned to identify patients who are at risk of developing hypertension (AH), in both pathologies the abnormalities in the variation of blood pressure (BP) has been related to organ damage, its evaluation is performed by ambulatory blood pressure monitoring (ABPM). Dapagliflozin is a selective and reversible inhibitor of the sodium-glucose co-transporter type 2 (SGLT-2), which reduces renal reabsorption of glucose and promotes the excretion of glucose through the urine, in the way that glucose blood. Another reported effects is the decrease on BP, so it would be interesting to evaluate this effects in patients with prediabetes and prehypertension, as a potential therapy to treat disorders and to prevent progression to DM2 and Hypertension, respectively. The aim of this study is to evaluate the effect of Dapagliflozin on variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment. The investigators hypothesis is that the administration of dapagliflozin decreases variability of blood pressure in patients with prediabetes and prehypertension without pharmacological treatment.

Key Dates

Start date
Mar 30, 2016
Status verified
Oct 2020
Primary completion
Mar 30, 2018
Completion
Jun 29, 2018

Study Design

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

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
  • Placebo Comparator: Placebo
    Placebo capsules, one per day before breakfast during 12 weeks.

Primary Outcome Measure

24-hours Systolic Blood Pressure at Week 12 [ Time Frame: Week 12 ]

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