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Exploratory study on the cardiovascular system of DPP-4 inhibitors in angina patients underwent PCI after complicated with type 2 diabetes

Phase 4
Conditions
Type 2 diabetic patients with angina pectoris who undergo percutaneous coronary intervention
Registration Number
JPRN-UMIN000011145
Lead Sponsor
Center for Clinical and Biomedical Research, Sapporo Higashi Tokushukai Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion Criteria

1) Type 1 diabetes mellitus 2) Severe diabetic ketosis, diabetic coma or total coma within 6 months 3) Patients who have 90% or more of the stenosis without PCI culprit lesion 4) Undergoing hemodialysis 5) Severe infectious disease ,before or after surgery, and sever trauma 6) Occurrence of ischemic stroke, hemorrhagic stroke or TIA within 6 months 7) Moderate or severe heart failure (NYHA III or IV) 8) Patients who did not receive DPP4 inhibitors during 3 month before starting study 9) Under treatment with insulin 10) Pregnant,lactating, possibly pregnant or planning to become pregnant women 11) Past medical history of hypersensitivity to linagliptin 12) Patients considered as inadequate by the principal investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1) The change of HbA1 at baseline and 8months after DPP-4 inhibitor treatment. 2) The change of plaque volume of non-culprit lesion at 8 months after PCI. 3) The change of virtual histology of non-culprit lesion segment at 8 months after PCI. 4) The co-relationship between HbA1c redaction and the change of plaque volume
Secondary Outcome Measures
NameTimeMethod
1) Plasma glucose 2) Serum lipids 3) Peripheral blood CD-34 positive cells 4) High sensitive CRP 5) BNP 6) Blood pressure 7) Body weight 8) Safety
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