Examination of the level of insulin antagonist hormones in hyperglycemic emergencies on admission.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046105

Enrollment

Registered

2021-11-18

Start date

2020-12-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: 1) A woman who is in lactation period or who may be pregnant.

Design outcomes

Primary

Measure	Time frame
the levels of insulin counter hormone (glucagon, catecholamine, growth hormone, and cortisol) on admission.	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactAgena Suzuki

Kitasato University, School of Medicine Department of diabetes, endocrinology and metabolism

agena.s@med.kitasato-u.ac.jp042-778-8706

Outcome results