Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension

NCT03006471 | Completed Phase 4 Results

• 1 other identifier: DAPA-BP variability
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PreDiabetes; Prehypertension

Keywords

Prediabetes; Prehypertension; Variability of blood pressure; ABPM; Dapagliflozin; SGLT2

Outcome Measures

Primary Outcomes (19)

• 24-hours Systolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

• 24-hours Diastolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

• Daytime Systolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 am. to 11 p.m. by oscillometric method Microlife WatchBP O3

  Week 12

• Daytime Diastolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to p.m. by oscillometric method Microlife WatchBP O3

  Week 12

• Nighttime Systolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m to 8 a.m. by oscillometric method Microlife WatchBP O3

  Week 12

• Nighttime Diastolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3

  Week 12

• Systolic Blood Pressure Weighted Standard Deviation at Week 12

  Blood pressure variability will be evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

• Diastolic Blood Pressure Weighted Standard Deviation at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

• Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

• Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

• Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m to 11 p.m. by oscillometric method Microlife WatchBP O3

  Week 12

• Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 8 a.m. to 11 p.m. by oscillometric method Microlife WatchBP O3

  Week 12

• Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3

  Week 12

• Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) from 11 p.m. to 8 a.m. by oscillometric method Microlife WatchBP O3

  Week 12

• Average Real Variability of Systolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

• Average Real Variability of Diastolic Blood Pressure at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

• Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

• Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

• Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12

  Blood pressure variability was evaluated with ambulatory blood pressure monitoring (ABPM) for 24 hours by oscillometric method Microlife WatchBP O3

  Week 12

Secondary Outcomes (14)

• Body Weight at Week 12

  Week 12

• Body Mass Index at Week 12

  Week 12

• Office Systolic Blood Pressure at Week 12

  Week 12

• Office of Diastolic Blood Pressure at Week 12

  Week 12

• Fasting Plasma Glucose Levels at Week 12

  Week 12

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo capsules, one per day before breakfast during 12 weeks.

Drug: Placebo - Cap

Interventions

Dapagliflozin DRUG

10 mg, one per day before breakfast during 12 weeks.

Also known as: Forxiga

Dapagliflozin

Placebo - Cap DRUG

one per day before breakfast during 12 weeks.

Also known as: Calcined magnesium

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Prediabetic State; Prehypertension

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: DR. MANUEL GONZALEZ ORTIZ
• Organization: INSITITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA

uiec@prodigy.net.mx

+52 3310585200

Study Officials

• MANUEL GONZALEZ, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 30, 2016
• Study Start: March 30, 2016
• Primary Completion: March 30, 2018
• Study Completion: June 29, 2018
• Last Updated: November 9, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-10

Locations

ME (1)