UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046105 |
|---|---|
| Receipt number | 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 | 2025/01/30 10:41:45 |
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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
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
agena.s@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University, School of Medicine
Institute
Department
Personal name
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
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
27
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It took time until the analysis was done.
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
Completed
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
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
no
Management information
Registered date
| 2021 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048840
