Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
Condition: Prediabetes; Impaired Fasting Glucose; Impaired Glucose Tolerance
MeSH terms: Insulin Resistance; Prediabetic State; Glucose Intolerance
Intervention: Dapagliflozin; Placebo
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: 24.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Prediabetes; Impaired fasting glucose; Hyperglycemia; Impaired glucose tolerance; Glucose intolerance; Dapagliflozin; Sodium glucose cotransporter 2 inhibitor; SGLT2

Summary:

      Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired
      fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of
      progression type 2 diabetes mellitus (T2DM).

      Dapagliflozin is a selective and reversible inhibitor of sodium-glucose type 2 (SGLT-2)
      co-transporter, which reduces renal glucose reabsorption and promotes the glucose excretion
      through urine, so that the blood glucose is improved in patients with T2DM. Although this
      mechanism is independent of insulin, there are evidence of improved secretion and insulin
      sensitivity, so it is interesting to assess these effects in patients with prediabetes, as
      potential therapy for treating such disorders and prevent progression to T2DM.

      The aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and
      insulin sensitivity in patients with prediabetes.

      The investigators hypothesis is that the administration of dapagliflozin improve insulin
      secretion and insulin sensitivity in patients with prediabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients both sexes

          -  Age between 30 and 60 years

          -  Diagnosis of prediabetes according ADA 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%)

          -  Informed consent signed

        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

          -  Body Mass Index ≥35 kg/m2

          -  Triglycerides ≥500 mg/dL

          -  Total cholesterol ≥240 mg/dL

          -  Low density lipoprotein (c-LDL) ≥190 mg/dL

          -  Blood Pressure ≥140/90 mmHg