UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical studies about diabetes and the neutrophilic elastase
Title of the study (Brief title)	Clinical studies about diabetes and the neutrophilic elastase
Region	Japan

Condition
Condition	type II diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.In the case of postcibal sudden elevation of glycemia, is a neutrophil activated? 2.Does the activation of this neutrophil change by taking diabetes remedy? 3.Is it different from a healthy person in this activation in patients with diabetes?
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum neutrophilic elastase concentrations
Key secondary outcomes	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)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key 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
Key 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)
Target sample size	45

Research contact person
Name of lead principal investigator	Takeshi Osonoi
Organization	Nakakinen clinic
Division name	Director
Address	745-5, Nakadai, Naka, Ibaraki
TEL	029-353-2800
Email	t-osonoi@kensei-kai.com

Public contact
Name of contact person	Kensuke Ofuchi
Organization	Nakakinen clinic
Division name	Clinical Laboratory
Address	745-5, Nakadai, Naka, Ibaraki
TEL	029-353-2800
Homepage URL
Email	k-ofuchi@kensei-kai.com

Sponsor
Institute	Nakakinen clinic
Institute
Department

Funding Source
Organization	SANWA KAGAKU KENKYUSHO CO.,LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Faculty of life Environmental Sciences,University of Yamanashi
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 22 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 04 Month 30 Day
Date trial data considered complete	2016 Year 05 Month 31 Day
Date analysis concluded	2016 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study. Case-control study. We Intend for all the members in an outpatient and the healthy adults who met criteria for selection. We measure serum neutrophils elastase concentrations, an inflammatory marker, an adhesion factor, blood glucose level

Management information
Registered date	2015 Year 07 Month 21 Day
Last modified on	2016 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021269