Development of hyperglycemic glucose clamp methods and evaluation of its outcomes in healthy subjects
Not Applicable
- Conditions
- Diabetes mellitus
- Registration Number
- JPRN-UMIN000020958
- Lead Sponsor
- SOUSEIKAI Hakata Clinic
- Brief Summary
Hyperglycemic state was maintained in all six subjects. Results of insulin and C-peptide indicated effectiveness of our methods to evaluate the first- and second- insulin secretory ability quantitatively. No AE including clinically significant decrease of Potassium was observed, and our methods were considered technically safe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
Not provided
Exclusion Criteria
1, Subjects with present and/or past illness considered inadequate for this study. 2, Subjects with past history of drug allergy. 3, Subjects with history of caffeine, alcohol and/or drug abuse. 4, Subjects who was judged not appropriate for this study by study physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of hyperglycemic glucose clamp technique. Evaluation of the parameters of the first- and second- insulin secretory ability, and the transitions of glucose, insulin and c-peptide
- Secondary Outcome Measures
Name Time Method Safety by evaluating AEs, serum potassium, and VAS for pain.