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

Sponsor
Beijing Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05171751
Collaborator
(none)
50
Enrollment
1
Location
1.5
Actual Duration (Months)
32.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Octreotide Injection

Detailed Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Dec 18, 2021
Actual Study Completion Date :
Dec 18, 2021

Outcome Measures

Primary Outcome Measures

  1. blood glucose [1 year]

    Maintain target blood glucose ≥3.3mmo/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Endocrinology, Genetics, Metabolism Beijing Beijing China 010

Sponsors and Collaborators

  • Beijing Children's Hospital

Investigators

  • Principal Investigator: bingyan cao, doctor, doctor of Beijing children's hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chunxiu Gong, director, Beijing Children's Hospital
ClinicalTrials.gov Identifier:
NCT05171751
Other Study ID Numbers:
  • octreotide-CHI-2021
First Posted:
Dec 29, 2021
Last Update Posted:
Dec 29, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Congenital Hyperinsulinism
Nesidioblastosis
Hypoglycemia
Octreotide

Study Results

No Results Posted as of Dec 29, 2021