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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial in 24 patients with a diagnosis
      of prediabetes in accordance with the American Diabetes Association (ADA) without treatment.

      They will be assigned randomly two groups of 12 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 Area Under the Curve of glucose and insulin, total insulin secretion
      (Insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin
      sensitivity (Matsuda index).

      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, will be used for
      differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups
      differences. It will be considered statistical significance p ≤0.05.

      This protocol was approved by a local ethics committee and written informed consent will be
      obtained from all volunteers.
    

Intervention name(s): Dapagliflozin; Placebo
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; Impaired fasting glucose; Hyperglycemia; Impaired glucose tolerance; Glucose intolerance; Dapagliflozin; Sodium glucose cotransporter 2 inhibitor; SGLT2