Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia

Completed

• Conditions: Congenital Hyperinsulinaemic Hypoglycaemia; Octreotide Adverse Reaction

• Registration Number: NCT05171751
• Lead Sponsor: Beijing Children's Hospital

Brief Summary

To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.

Detailed Description

Octreotide subcutaneous injection is effective and safe in the treatment of congenital hyperinsulinemia in children with inefficacy of diazazine.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-05
• Status Verified: 2021-12
• Primary Completion: 2021-12-18
• Study Completion: 2021-12-18
• Study First Submitted QC: 2021-12-19
• Last Update Submitted: 2021-12-19
• Study First Posted: 2021-12-29
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Consistent with the diagnosis of congenital hyperinsulinemia with ineffective diazine; With the maximum dose of diazine at 15mg/kg/d for 5 days, fasting blood glucose/postprandial blood glucose could not be stabilized at the target value of 3.3mmol/L without intravenous glucose infusion.
2. patients treated with octreotide subcutaneous injection.

Exclusion Criteria

1. Before the diagnosis of CHI and the treatment related to CHI, the child had received total pancreatectomy without octreotide
2. Secondary hypoglycemia caused by diseases other than CHI
3. Patients who refused to take octreotide due to parents or family economic reasons, but not hospital treatment factors.
4. Patients who intervene/interfere with octreotide treatment regimen for parental reasons

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood glucose	1 year	Maintain target blood glucose ≥3.3mmo/L

Trial Locations

Locations (1)

Department of Endocrinology, Genetics, Metabolism; 🇨🇳 Beijing, Beijing, China