Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension
Condition: PreDiabetes; Prehypertension
MeSH terms: Prehypertension; Prediabetic State; Glucose Intolerance
Intervention: Dapagliflozin; Placebo - Cap
Intervention description: 10 mg, one per day before breakfast during 12 weeks.; one per day before breakfast during 12 weeks.
Intervention MeSH terms: Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Prediabetes; Prehypertension; Variability of blood pressure; ABPM; Dapagliflozin; SGLT2

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent signed

          -  Patients both sexes, age between 30 and 60 years

          -  Diagnosis of prediabetes according American Diabetes Association criteria (fasting
             blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an
             oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or
             glycosylated hemoglobin between 5.7-6.4%)

          -  Diagnosis of prehypertension according (JNC8) Eighth Joint National Committee blood
             pressure between 120-139/ 80-89 mmHg.

        Exclusion Criteria:

          -  Women with confirmed or suspected pregnancy

          -  Women under lactation and/or puerperium

          -  Hypersensibility to ingredients of intervention

          -  Physical impossibility for taking pills

          -  Known uncontrolled renal, hepatic, heart or thyroid diseased

          -  Diabetes diagnosis

          -  Previous treatment for glucose or blood pressure Triglycerides ≥400 mg/dL

          -  Total cholesterol ≥240 mg/dL

          -  History of cardiovascular disease

          -  Worker per shift / night