Clinical studies about diabetes and the neutrophilic elastase

Not Applicable

• Conditions: type II diabetes mellitus

• Registration Number: JPRN-UMIN000018370
• Lead Sponsor: akakinen clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-18
• Study Completion: 2016-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Healthy adult exclusion criteria of Japanese people (1) Person with the clinical history (2) The person who suffers trauma, and is treated (3) Person with the medical history that judged that a researcher had an influence on the evaluation of the safety of subjects and the study (4) Drug dependence, a person with the alcohol dependence or person with the history (5) A person with sensitivity to drug or person with the history (6) A person with the food allergy or person with the history (7) The daily persons who smokes an average of ten or more (8) Excessive common custom drinker (9) Person with positive at least one among examinations of HIV antigen, antibody, HBs antigen, HCV antibody and syphilis (10) In addition, the person who judged that an investigator or a subinvestigator was inadequate. Exclusion criteria of patients with Japanese type II diabetes mellitus (1) Patients with type I diabetes mellitus (2) The patients who are judged to need treatment with insulin preparation (3) The patients with the serious hepatic disorder (4) The patients with serious renal disease (5) The patients who blood pressure management is insufficient, and need a change of the pharmacotherapy immediately (6) The patients with the serious heart disorder or the patients who caused myocardial infarction, an anginal attack within 24 weeks before study start (7) The patients who had a stroke attack within 24 weeks before study start (8) The patients with serious impaired pulmonary function (9) The patients with the serious pancreatic disease (10) The patients with the malignant tumor (11) Severe infection, before and after surgery, the patients with the serious trauma (12) The patients with severe diabetic complications (neuropathy, retinopathy, nephropathy) (13) Severe ketosis, diabetic coma or the former comatose patients (14) The endocrine disease that treatment is inadequate for by hormone replacement therapy (15) The patients with severe anemia (16)-(26)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum neutrophilic elastase concentrations

Secondary Outcome Measures

Name	Time	Method
Blood glucose level Gene expression (three hours before a meal after meal) of the peripheral blood leukocyte fraction inflammatory cytokine (IL-1b, TNFa) adhesion factor (CD11b, CD11c) Pro-metabolism factor (IRS-1)