Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03006471
• Date of registration: 13/12/2016
• Prospective Registration: No
• Primary sponsor: University of Guadalajara
• Public title: Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension
• Scientific title: Effect of Dapagliflozin on Blood Pressure Variability in Patients With Prediabetes and Prehypertension Without Pharmacological Treatment
• Date of first enrolment: March 30, 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03006471
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Mexico

Contacts

• Name: MANUEL GONZALEZ, PhD
• Affiliation: University of Guadalajara

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

PreDiabetes

Prehypertension

Intervention(s)

Drug: Dapagliflozin

Drug: Placebo - Cap

Primary Outcome(s)

Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12 [Time Frame: Week 12]

Daytime Diastolic Blood Pressure at Week 12 [Time Frame: Week 12]

Daytime Systolic Blood Pressure at Week 12 [Time Frame: Week 12]

Systolic Blood Pressure Weighted Standard Deviation at Week 12 [Time Frame: Week 12]

Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12 [Time Frame: Week 12]

Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12 [Time Frame: Week 12]

Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12 [Time Frame: Week 12]

24-hours Diastolic Blood Pressure at Week 12 [Time Frame: Week 12]

Diastolic Blood Pressure Weighted Standard Deviation at Week 12 [Time Frame: Week 12]

Nighttime Diastolic Blood Pressure at Week 12 [Time Frame: Week 12]

Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12 [Time Frame: Week 12]

Nighttime Systolic Blood Pressure at Week 12 [Time Frame: Week 12]

Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12 [Time Frame: Week 12]

24-hours Systolic Blood Pressure at Week 12 [Time Frame: Week 12]

Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12 [Time Frame: Week 12]

Average Real Variability of Diastolic Blood Pressure at Week 12 [Time Frame: Week 12]

Average Real Variability of Systolic Blood Pressure at Week 12 [Time Frame: Week 12]

Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12 [Time Frame: Week 12]

Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Body Mass Index at Week 12 [Time Frame: Week 12]

Glycated Hemoglobin A1c (A1C) at Week 12 [Time Frame: Week 12]

Body Weight at Week 12 [Time Frame: Week 12]

Office Systolic Blood Pressure at Week 12 [Time Frame: Week 12]

2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12 [Time Frame: Week 12]

Number of Participants With Prehypertension at Week 12 [Time Frame: Week 12]

Daytime Hypertensive Load at Week 12 [Time Frame: Week 12]

Nocturnal Hypertensive Load at Week 12 [Time Frame: Week 12]

Office of Diastolic Blood Pressure at Week 12 [Time Frame: Week 12]

Daytime Mean Arterial Pressure at Week 12 [Time Frame: Week 12]

Number of Participants With Prediabetes at Week 12 [Time Frame: Week 12]

Fasting Plasma Glucose Levels at Week 12 [Time Frame: Week 12]

Nighttime Mean Arterial Pressure at Week 12 [Time Frame: Week 12]

Number of Participants With Prediabetes Plus Prehypertension at Week 12 [Time Frame: Week 12]

Secondary ID(s)

DAPA-BP variability

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03006471