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

NCT05171751 | Completed

• 1 other identifier: octreotide-CHI-2021
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Hyperinsulinaemic Hypoglycaemia; Octreotide Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• blood glucose

  Maintain target blood glucose ≥3.3mmo/L

  1 year

Interventions

Octreotide Injection DRUG

Octreotide subcutaneous injection for congenital hyperinsulinemia with ineffective diazine

Also known as: glucose

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Children's Hospital: lead

Study Sites (1)

Department of Endocrinology, Genetics, Metabolism

Beijing, Beijing Municipality, 010, China

Location

MeSH Terms

Interventions

Octreotide; Glucose

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• bingyan cao, doctor

  doctor of Beijing children's hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 29, 2021
• Study Start: November 1, 2021
• Primary Completion: December 18, 2021
• Study Completion: December 18, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

CN (1)