Phase 4 N=30 Randomized Double-blind Treatment

Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension

PreDiabetes · Prehypertension

Bottom Line

View on ClinicalTrials.gov: NCT03006471 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: 24-hours Systolic Blood Pressure at Week 12 — 117; 120 mmHg — p=0.755

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dapagliflozin (Drug); Placebo - Cap (Drug)
Age: Adult · 30+ yrs
Sex: All
Sponsor: University of Guadalajara
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY 24-hours Systolic Blood Pressure at Week 12	117; 120	0.755
PRIMARY 24-hours Diastolic Blood Pressure at Week 12	73; 75	0.752
PRIMARY Daytime Systolic Blood Pressure at Week 12	121; 122	0.814
PRIMARY Daytime Diastolic Blood Pressure at Week 12	76; 77	0.624
PRIMARY Nighttime Systolic Blood Pressure at Week 12	108; 115	0.906
PRIMARY Nighttime Diastolic Blood Pressure at Week 12	67; 72	0.454
PRIMARY Systolic Blood Pressure Weighted Standard Deviation at Week 12	9.8; 10.3	0.422
PRIMARY Diastolic Blood Pressure Weighted Standard Deviation at Week 12	8.0; 8.3	0.650
PRIMARY Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12	9.9; 9.5	0.875
PRIMARY Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12	12.3; 11.3	0.552
PRIMARY Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12	7.7; 8.4	0.814
PRIMARY Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12	10.2; 9.2	0.530
PRIMARY Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12	8.4; 10.6	0.152
PRIMARY Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12	12.3; 13.5	0.152
PRIMARY Average Real Variability of Systolic Blood Pressure at Week 12	10.0; 9.2	0.944
PRIMARY Average Real Variability of Diastolic Blood Pressure at Week 12	6.8; 7.0	0.087
PRIMARY Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12	4; 8	0.115
PRIMARY Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12	8; 3	0.047 sig
PRIMARY Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12	1; 2	0.539
SECONDARY Body Weight at Week 12	73; 78	0.844
SECONDARY Body Mass Index at Week 12	28; 29	0.814
SECONDARY Office Systolic Blood Pressure at Week 12	119; 130	0.221
SECONDARY Office of Diastolic Blood Pressure at Week 12	75; 82	0.461
SECONDARY Fasting Plasma Glucose Levels at Week 12	5.8; 6.1	0.285
SECONDARY 2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12	7.8; 8.3	0.701
SECONDARY Glycated Hemoglobin A1c (A1C) at Week 12	5.4; 5.9	0.581
SECONDARY Daytime Mean Arterial Pressure at Week 12	92; 92	0.727
SECONDARY Nighttime Mean Arterial Pressure at Week 12	84; 87	0.463
SECONDARY Daytime Hypertensive Load at Week 12	28.6; 34.1	0.807
SECONDARY Nocturnal Hypertensive Load at Week 12	38.1; 52.0	0.507
SECONDARY Number of Participants With Prediabetes at Week 12	7; 2	0.039 sig
SECONDARY Number of Participants With Prehypertension at Week 12	7; 1	0.011 sig
SECONDARY Number of Participants With Prediabetes Plus Prehypertension at Week 12	4; 0	0.096

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03006471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.