UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018370 |
|---|---|
| Receipt number | R000021269 |
| Scientific Title | Clinical studies about diabetes and the neutrophilic elastase |
| Date of disclosure of the study information | 2015/08/18 |
| Last modified on | 2016/09/06 19:14:55 |
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Basic information
Public title
Clinical studies about diabetes and the neutrophilic elastase
Acronym
Clinical studies about diabetes and the neutrophilic elastase
Scientific Title
Clinical studies about diabetes and the neutrophilic elastase
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takeshi Osonoi |
Organization
Nakakinen clinic
Division name
Director
Zip code
Address
745-5, Nakadai, Naka, Ibaraki
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Ofuchi |
Organization
Nakakinen clinic
Division name
Clinical Laboratory
Zip code
Address
745-5, Nakadai, Naka, Ibaraki
TEL
029-353-2800
Homepage URL
k-ofuchi@kensei-kai.com
Sponsor or person
Institute
Nakakinen clinic
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021269
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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