SGLT-2i and ARB combination therapy in patients with T2DM and nocturnal hypertensio
- Conditions
- Patients with T2DM and nocturnal hypertension
- Registration Number
- JPRN-UMIN000024973
- Lead Sponsor
- Jichi Medical University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 176
Not provided
Patients who meet any of the following criteria are not eligible for the study: -History of hypersensitivity to empagliflozin -Breast-feeding, pregnant, possibly pregnant, or plan to become pregnant -Treated with insulin or SU -With renal dysfunction (eGFR<45mL/min/1.73m2) -With liver dysfunction (AST or ALT is 3 times higher than reference value) -Hypotension (systolic blood pressure < 90 mmHg) -With pituitary gland dysfunction or adrenal gland dysfunction -Heart failure patients whose NYHA class is IV -Deemed ineligible for the study due to another reason by investigator -History of diabetic ketoacidosis or diabetic come within 3 months before enrollment -History of Acute myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before enrollment -Patients who have undergone percutaneous transluminal coronary angioplasty (PCI) or coronary artery bypass graftin (CABG) within 3 months before enrollment -Patients received SGLT2 inhibitor within 8 weeks before enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method octurnal BP measured by ABPM
- Secondary Outcome Measures
Name Time Method 1)Blood pressure (systolic blood pressure/diastolic blood pressure and pulse rate) -ABPM parameters (24-h BP, Daytime BP, minimum nocturnal BP, nocturnal BP variability) 2)Metabolism-related factors HbA1c, Body weight, Height, BMI, Lipids, Uric acid, HOMA-R, HOMA-beta 3)Sleep efficacy -Sleep scale (Athens insomnia scale) -Frequency of nocturnal awakening -Frequency of nocturia 4)Measures of circulating volume Plasma NT-proBNP, ANP 5)Measures of organ damage Urinary albumin/creatinine excretion ratio, Urinary Na/K, eGFR, cystatinC 6)Other measurement -The correlation between BP and blood glucose control -The correlation between BP and body weight