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

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 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

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

Value
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