Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area
- Conditions
- Type 2 diabetes mellitus.
- Registration Number
- JPRN-UMIN000013191
- Lead Sponsor
- Takeda Hospital Medical Examination Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
Not provided
1)Type 2 diabetic patients (HbA1c(NGSP value),higher than 6.5% but lower than 9.0%) 2) Patients who can begin treatment linagliptin this study, but patients who had taken other DPP-4 inhibitor. (Not washout period) 3) Patients who are stably treating with lipid-lowering drugs or Anti-hypertension drugs 4) Age,20-80(Male and female) 5) Written informed consent are taken for the enrollment 1) Patients who are Type I or Secondary diabetic mellitus 2) Patients who are treating with GLP-1 agonist or Thiazolidinedione at the time of study initiation 3) Patients who are severe infectious disease, perioperative, and severe trauma 4)Patients with myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction 5) Patients with moderate or severer heart failure (NYHA/New York Heart Association stage 3 or severer) 6) Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant 7) Patients with a history of hypersensitivity to investigational drugs 8) Patients with cancer 9) Patients who receive steroid therapy with inflammatory affection 10) Patients whom doctor judges as ineligible to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of ECG (Heart rate variability, QT variability) and visceral fat area and subcutaneous fat area by BIA from baseline (Visit 0) to 12 and 24 weeks.
- Secondary Outcome Measures
Name Time Method