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

December 19, 2021 updated by: Chunxiu Gong, Beijing Children's Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 010
        • Department of Endocrinology, Genetics, Metabolism

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood glucose
Time Frame: 1 year
Maintain target blood glucose ≥3.3mmo/L
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Children's Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2021

Primary Completion (ACTUAL)

December 18, 2021

Study Completion (ACTUAL)

December 18, 2021

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

December 19, 2021

First Posted (ACTUAL)

December 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 19, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • octreotide-CHI-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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