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CompletedNCT05171751BCHUpdated Dec 29, 2021

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

An observational study in Congenital Hyperinsulinaemic Hypoglycaemia and Octreotide Adverse Reaction, sponsored by Beijing Children's Hospital. Completed at 1 site in China. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2021-12-29.

Sponsored by Beijing Children's Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
50
Ages
1 Month to 18 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Congenital Hyperinsulinaemic Hypoglycaemia
  • Octreotide Adverse Reaction
03

In context

Congenital Hyperinsulinism

46 studies on the registry are indexed under Congenital Hyperinsulinism; 7 are open to participants now.

Browse Congenital Hyperinsulinism studies →

Lead sponsor

Beijing Children's Hospital is the lead sponsor of 51 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children with congenital hyperinsulinemia who received octreotide subcutaneous injection after diazazine treatment failed.

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

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
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • DrugOctreotide Injection

    Octreotide subcutaneous injection for congenital hyperinsulinemia with ineffective diazine

    Also known as: glucose

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What researchers measure

Primary outcomes

  1. blood glucose

    Maintain target blood glucose ≥3.3mmo/L

    Time frame: 1 year

07

Study locations

1 site
  • Department of Endocrinology, Genetics, Metabolism
    Beijing, Beijing 010, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05171751
Lead sponsor
Beijing Children's Hospital
Responsible party
Chunxiu Gong (director, Beijing Children's Hospital) — Principal investigator
First posted
Dec 29, 2021
Start date
Nov 1, 2021
Primary completion
Dec 18, 2021
Completion
Dec 18, 2021
Last update
Dec 29, 2021

Study contacts

bingyan cao, doctor
principal investigator · doctor of Beijing children's hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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