type II diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Nakakinen clinic
Faculty of life Environmental Sciences,University of Yamanashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy adult criteria for selection of Japanese people (1) Age at agreement acquisition is a person younger than 60 years 20 years old or older (2) The person that BMI (weight (kg) / [height (m) X height (m)]) at agreement acquisition is less than 25.0 more than 18.5 (3) The person whom a researcher judged to be eligible as subjects of this study (4) Criteria for selection of patients with person Japanese type II diabetes mellitus that has the ability of the agreement, and is available for the acquisition of the document agreement from the person (1) The patients who give a diet or a diet, exercise therapy in the instructions contents which are more constant than before more than study initiation eight weeks (2) The patients whom we are treated with miglitol (50 mg of once or 75 mg 3 times a day) from before more than study initiation eight weeks and do not change within eight weeks (3) The patients more than 6.5% with HbA1c at agreement acquisition less than 8.5% (4) Age at agreement acquisition is the patient younger than 75 years 20 years old or older (5) The patients who have the ability of the agreement, and are available for the acquisition of the document agreement from the person
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum neutrophilic elastase concentrations | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactKensuke Ofuchi
Nakakinen clinic Clinical Laboratory
Outcome results
None listed