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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024453
Receipt No. 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

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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
Email 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
Email takuwatanabe-circ@umin.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028057

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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