Introduction of indices of clinical insulin resistance / sensitivity under significant urinary glucose excretio

Not Applicable

• Conditions: diabetes mellitus

• Registration Number: JPRN-UMIN000014171
• Lead Sponsor: Department of Endocrinology and Diabetes Saitama Medical Center, Saitama Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1) Under the treatment with insulin 2) Type 1 diabetic subjects or diabetic subjects who have HbA1c more than or equal to 8.0 % or who need admission because of diabetic ketoacidosis or extreme hyperglycemia. 3) Subjects who are treated with sulfonylureas (i.e. glibenclamide, glimepiride, or gliclazide). 4) Subjects with nephrotic syndrome (urine protein more than or equal to 3.5g/day and serum protein less than or equal to 6.0 g/dl [or serum albumin less than or equal to 3.0 g/dl]. 5) Subjects who are taking steroids, immune suppression medication, antifungal medication of azoles. HIV protease inhibitors 6) Subjects who had brain stroke or acute coronary syndrome within 6 months before enrollment. 7) Subjects with severe heart failure (NYHA class 3 or higher), severe arrhythmia (frequent atrial or ventral arrhythmia, continuous ventricular tachycardia, severe atrial tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome or atrial-ventral block with severe bradycardia). 8) Subjects who have AST or ALT more than 5 times of upper normal limit of their institute 9) Subjects with malignancy 10) Subjects who are pregnant or who have intention to be pregnant 11) Subjects with other situations under which a doctor in charge decides that subjects are not eligible for this study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of muscle insulin sensitivity and liver insulin resistance (should be consistant to the effect of SGLT-2 inhibitors, when compared with previous studies)

Secondary Outcome Measures

Name	Time	Method
1)Exsitence of difference between the new indices and HOMA-IR or Matsuda index without considering urine glucose excretion 2)Consistence of beta cell function measured by HOMA-beta or insulinogenic inex 3)Any changes in the disposition index 4)Existance of urinary glucose excretion after terminatio of SGLT-2 inhibitors