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Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area

Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area - Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013191
Enrollment
30
Registered
2014-02-20
Start date
2014-02-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus.

Interventions

Sponsors

Takeda Hospital Medical Examination Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactIzuru Masuda

Takeda Hospital Medical Examination Center

imasuda@kuhp.kyoto-u.ac.jp075-365-0825

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026