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

NCT ID: NCT05171751

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2021-12-18

Brief Summary

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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

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

Conditions

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Congenital Hyperinsulinaemic Hypoglycaemia Octreotide Adverse Reaction

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Octreotide Injection

Octreotide subcutaneous injection for congenital hyperinsulinemia with ineffective diazine

Intervention Type DRUG

Other Intervention Names

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glucose

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chunxiu Gong

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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bingyan cao, doctor

Role: PRINCIPAL_INVESTIGATOR

doctor of Beijing children's hospital

Locations

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Department of Endocrinology, Genetics, Metabolism

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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octreotide-CHI-2021

Identifier Type: -

Identifier Source: org_study_id