UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024453 |
|---|---|
| Receipt number | R000028057 |
| Scientific Title | Study of insulin resistance evaluation method using a simple insulin tolerance test in diabetic patients |
| Date of disclosure of the study information | 2016/10/25 |
| Last modified on | 2021/04/28 12:32:55 |
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Basic information
Public title
Study of insulin resistance evaluation method using a simple insulin tolerance test in diabetic patients
Acronym
simple insulin tolerance test
Scientific Title
Study of insulin resistance evaluation method using a simple insulin tolerance test in diabetic patients
Scientific Title:Acronym
simple insulin tolerance test
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For diabetes patients in the education admitted to our hospital, we make a study of whether a simple insulin tolerance test is useful in the evaluation of insulin resistance.In addition, to examine the relationship between the maximum insulin usage and insulin resistance it took to get a good blood sugar control.Furthermore, because of the stratification of insulin resistance due to the presence or absence of abnormal glucose tolerance, a simple insulin tolerance test even for volunteers has never been pointed out diabetes in the past, compared to enforce SITT method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation of K index of ITT(Kitt) that is a loss rate of blood sugar of up to 15 minutes -90 minutes of simple insulin tolerance test and Kitt of short insulin tolerance test.
Key secondary outcomes
1.The maximum insulin usage it took to get a good blood sugar control
2.Adverse event
3.Insulin resistance index (HOMA-IR, Kitt) associated with other clinical indicators, such as the blood in the amino acid values, body composition analysis results analysis
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
<Study1>
Two tests are carried out in a crossover;a simple insulin tolerance test by subcutaneous injection of 0.1 units / kg body weight of insulin and a short insulin tolerance test by intravenous injection of 0.1 units / kg body weight of insulin.
Interventions/Control_2
<Study2>
A simple insulin tolerance test are carried out in two consecutive days.
Each test is completed in the morning.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Selection criteria (inpatient)
1. Patient age 20 years of age or older at the time of obtaining informed consent
2. Ppatient with early morning fasting blood glucose greater than or equal to 140 mg/dl at the next day of hosiptalization
3. After receiving a sufficient explanation on participation in this study, on a thorough understanding, patient document consent of the free will of the person has been obtained
Selection criteria (volunteer)
1. Age is 30 years of age or older at the time of obtaining informed consent, and BMI 18.5kg/m2 or more persons
2. Person in the past have not been noted diseases which present with diabetes or hypoglycemia
3. After receiving a sufficient explanation on participation in this study, on a thorough understanding, document consent of the free will of the person has been obtained
Key exclusion criteria
Exclusion criteria (inpatient)
Who 1. state of diabetic retinopathy is not stable
2. diabetic nephropathy stage 4 or more persons
Who 3. have merged the untreated ischemic heart disease
4. epilepsy patients
5. for the components of the drug to be used in the present study, a person with a history of hypersensitivity
6. pregnant women, there might have been lactation or pregnancy who
7. other, who principal investigator or research division deems unsuitable as research subjects
Exclusion criteria (volunteer)
Who 1. in the past has been pointed out the diseases which present with low blood glucose (less than glucose 60 mg/dl)
2. for the components of the drug to be used in the present study, a person with a history of hypersensitivity
3. pregnant women, there might have been lactation or pregnancy who
4. Less than 30 years of age, and BMI 18.5kg/m2 less than those who
Who 5. have merged the untreated ischemic heart disease
6. epilepsy patients
7. other, who principal investigator or research division deems unsuitable as research subjects
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Watanabe |
Organization
Hokkaido University Hospital
Division name
First Department of Medicine
Zip code
060-8648
Address
Kita14 Nishi5, Kita-ku, Sappro, 060-8648,Japan
TEL
011-706-5911
takuwatanabe-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Watanabe |
Organization
Hokkaido University Hospital
Division name
First Department of Medicine
Zip code
060-8648
Address
Kita14 Nishi5, Kita-ku, Sappro, 060-8648,Japan
TEL
011-706-5911
Homepage URL
takuwatanabe-circ@umin.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address
Kita14 Nishi5, Kita-ku, Sappro, 060-8648,Japan
Tel
011-701-7636
crjimu@huhp.hokudai.ac.jp
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
| 2016 | Year | 10 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 18 | Day |
Last modified on
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028057
