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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046105
Receipt No. R000048840
Scientific Title A single-center, prospective, observational study investigating the level of insulin antagonist hormones in diabetic ketosis and hyperglycemic emergencies on admission.
Date of disclosure of the study information 2021/11/18
Last modified on 2021/11/18

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Basic information
Public title Examination of the level of insulin antagonist hormones in hyperglycemic emergencies on admission.
Acronym Examination of the level of insulin antagonist hormones in hyperglycemic emergencies on admission.
Scientific Title A single-center, prospective, observational study investigating the level of insulin antagonist hormones in diabetic ketosis and hyperglycemic emergencies on admission.
Scientific Title:Acronym A single-center, prospective, observational study investigating the level of insulin antagonist hormones in diabetic ketosis and hyperglycemic emergencies on admission.
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the level of insulin antagonist hormones in diabetic ketosis and hyperglycemic emergencies on admission.
Basic objectives2 Others
Basic objectives -Others We examine the level of insulin antagonist hormones in diabetic ketosis and hyperglycemic emergencies (diabetic ketoacidosis and hyperosmolar hyperglycemic state) on admission, and elucidate the effects of the hormones on these conditions.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the levels of insulin counter hormone (glucagon, catecholamine, growth hormone, and cortisol) on admission.
Key secondary outcomes the levels of insulin, plasma glucose, hemoglobin A1c (HbA1c), glycated albumin (GA), C-peptide, glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), BUN and ketone body on admission

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) A person who is 16 years or older at the time of obtaining consent.
2) A person who is diagnosed diabetic ketosis or hyperglycemic emergency (diabetic ketoacidosis or hyperosmolar hyperglycemic state). In addition, each condition is defined as follows.
a) Diabetic ketosis : pH >= 7.30, and HCO3- >= 18 mEq/L, and ketone is positive.
b) Diabetic ketoacidosis : plasma glucose level > 250 mg/dL, and pH < 7.30, and/or HCO3- < 18 mEq/L, and keton is positive.
c) Hyperosmolar hyperglycemic state : plasma glucose level > 600 mg/dL, and pH >= 7.30, and HCO3- >= 18 mEq/L, and ketone is negative, and plasma osmorality >= 320 mOsm/kg.
3) When the age of a person is between 16 and 19 years at the time of obtaining consent, the person and his/her substitute understand the content of this study and can obtain written consent to participate in the study on sufficient explanation.
4) When a person's Glasgow coma scale is less than or equal 14 points at the time of obtaining consent, sufficient explanation should be given to his/her substitute for participation in this study. Futhermore, the person with the substitute's written consent will participate in the study. We should give sufficient explanation to the person after improving the consciousness level. The person understands the content of this study and can obtain written consent to participate in the study.
5) A person who understands the content of this study and can obtain written consent to participate in the study.
Key exclusion criteria 1) A woman who is in lactation period or who may be pregnant.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Agena
Middle name
Last name Suzuki
Organization Kitasato University, School of Medicine
Division name Department of diabetes, endocrinology and metabolism
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa-Pref, Japan
TEL 042-778-8706
Email agena.s@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Agena
Middle name
Last name Suzuki
Organization Kitasato University, School of Medicine
Division name Department of diabetes, endocrinology and metabolism
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa-Pref, Japan
TEL 042-778-8706
Homepage URL
Email agena.s@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University, School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Obsevation and Epidemiological study
Address Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa, Kanagawa
Tel 042-778-8273
Email rinri-n@kitasato-u.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
2021 Year 11 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 Open public recruiting
Date of protocol fixation
2020 Year 12 Month 03 Day
Date of IRB
2020 Year 12 Month 03 Day
Anticipated trial start date
2020 Year 12 Month 03 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information no

Management information
Registered date
2021 Year 11 Month 18 Day
Last modified on
2021 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048840

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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