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

JRCT ID: jRCT1030200267

Registered date:24/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: diabetes mellitus
• Date of first enrollment: 24/12/2020
• Target sample size: 30
• Study type: Observational

Outcome(s)

• Primary Outcome: the levels of insulin, glucagon, catecholamin, growth hormone and cortisol on admission
• Secondary Outcome: the level of 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

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

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

Related Information

• Primary Sponsor: Suzuki Agena