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Completed

NCT Number: NCT05171751

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

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

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Key information

Conditions

Congenital Hyperinsulinaemic Hypoglycaemia Octreotide Adverse Reaction

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Endocrinology, Genetics, Metabolism

Beijing, Beijing Municipality, 010, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • patients treated with octreotide subcutaneous injection.

Exclusion criteria

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

Treatment and study plan

Octreotide Injection

Drug

Octreotide subcutaneous injection for congenital hyperinsulinemia with ineffective diazine

Other names: glucose

Primary outcomes

  1. blood glucose

    Time frame: 1 year

    Maintain target blood glucose ≥3.3mmo/L

Sponsors and collaborators

Lead sponsor

Beijing Children's Hospital

Other

Registry information

Official study title

Beijing Children's Hospital, Capital Medical University, National Center for Children's Health

Acronym: BCH

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2021
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.