Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension
NCT ID: NCT03006471
Last Updated: 2020-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2016-03-30
2018-06-29
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin
10 mg, one per day before breakfast during 12 weeks.
Placebo
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap
one per day before breakfast during 12 weeks.
Interventions
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Dapagliflozin
10 mg, one per day before breakfast during 12 weeks.
Placebo - Cap
one per day before breakfast during 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
60 Years
ALL
No
Sponsors
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University of Guadalajara
OTHER
Responsible Party
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Manuel González Ortiz
PhD
Principal Investigators
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MANUEL GONZALEZ, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Guadalajara
Locations
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Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico
Countries
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Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DAPA-BP variability
Identifier Type: -
Identifier Source: org_study_id