UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028057