Continuous subcutaneous injection of octreotide for congtenital hyperinsulinism: efficacy and safety.
Not Applicable
- Conditions
- congenital hyperinsulinism
- Registration Number
- JPRN-UMIN000012620
- Lead Sponsor
- Japan Agency for Medical Research and Development. Research group for the study on "Efficacy and safety of subcutaneous continuous octreotide infusion for congenital hyperinsulinism."
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
Not provided
Exclusion Criteria
1) Hypoglycemic patients with causes other than hyperinsulinemia. 2) Patients with severe extrapancreatic comorbidities. a. intestinal dysfunction b. respiratory failure c. severe liver dysfunction with transaminases or bilirubin > 3x ULN for age. d. renal failure with urea nitrogen or creatinine > 3x ULN for age. e. patient with other comorbidities who would not be appropriate for enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Short term increase in blood glucose comparing the mean blood glucose before 24 hours and after 48 hours of the initiation of the treatment.
- Secondary Outcome Measures
Name Time Method 1) Long-term reduction in the amount of glucose infusion to maintain blood glucose at 1 week, 2 weeks, 4 weeks, and at every 3 month after 5 weeks. 2) Neurological outcome after > 1 year of the initiation of the treatment. 3) Number of ypoglycemic episodes < 45 mg/dL during the treatment, categorized as asymptomatic, symptomatic, or severe.