Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension
Condition: PreDiabetes; Prehypertension
MeSH terms: Prehypertension; Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial in 30 patients with a diagnosis
      of prediabetes and prehypertension without treatment.

      They will be assigned randomly two groups of 15 patients each to receive 10 mg of
      Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12
      weeks.

      There will be calculated body mass index (BMI) and blood pressure variability. This protocol
      it's already approved by the local ethics committee and written informed consent it's going
      to be obtained from all volunteers.

      Statistical analysis will be presented through measures of central tendency and dispersion,
      average and deviation standard for quantitative variables; frequencies and percentages for
      variable qualitative. Qualitative variables will be analyzed by X2/ exact fisher test, will
      be used for differences inter-group Mann-Whitney U Test and coefficient of variation,
      Wilcoxon Test and index of variability for the within-groups differences. It will be
      considered statistical significance p ≤0.05.
    

Intervention name(s): Dapagliflozin; Placebo - Cap
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg, one per day before breakfast during 12 weeks.; one per day before breakfast during 12 weeks.
Other intervention name(s): Forxiga; Calcined magnesium
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Prediabetes; Prehypertension; Variability of blood pressure; ABPM; Dapagliflozin; SGLT2