Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension
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.
Timeline
- Start
- 2016-03-30
- Primary completion
- 2018-03-30
- Completion
- 2018-06-29
Outcome
Mixed primary results
registry COUNT_OF_PARTICIPANTS Dapagliflozin: 8 Participants NCT03006471 ↗
registry COUNT_OF_PARTICIPANTS Placebo: 3 Participants NCT03006471 ↗
registry analysis (superiority test); Dapagliflozin vs Placebo; p = 0.047; Chi-squared; note: The threshold for statistical significance was p=0.05 NCT03006471 ↗
registry analysis (superiority test); Dapagliflozin vs Placebo; p = 0.115; Chi-squared; note: The threshold for statistical significance was p=0.05 NCT03006471 ↗
registry analysis (superiority test); Dapagliflozin vs Placebo; p = 0.539; Chi-squared; note: The threshold for statistical significance was p=0.05 NCT03006471 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | — |