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Clinical Trials/JPRN-jRCT1030200267
JPRN-jRCT1030200267
Recruiting
未知

A single-center, prospective, observational study investigating the levels of insulin antagonist hormones on diabetic ketosis and hyperglycemic emergencies on admission

Suzuki Agena0 sites30 target enrollmentDecember 24, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
diabetes mellitus
Sponsor
Suzuki Agena
Enrollment
30
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 24, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Suzuki Agena

Eligibility Criteria

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.

Exclusion Criteria

  • 1\) A woman who is in lactation period or who may be pregnant.

Outcomes

Primary Outcomes

Not specified

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