Congenital Hyperinsulinaemic HypoglycaemiaBCHNCT05171751
Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia
An observational study of Congenital Hyperinsulinaemic Hypoglycaemia and Octreotide Adverse Reaction, run by Beijing Children's Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Congenital Hyperinsulinaemic Hypoglycaemia, Octreotide Adverse Reaction
- What is being tested?
- Octreotide Injection
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 18 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with congenital hyperinsulinemia who received octreotide subcutaneous injection after diazazine treatment failed.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, Genetics, Metabolism
Beijing, Beijing Municipality, 010
About this study
Official title: 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.
Read the detailed description
Octreotide subcutaneous injection is effective and safe in the treatment of congenital hyperinsulinemia in children with inefficacy of diazazine.
- Being tested
- Octreotide Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide InjectionDrug
Also called glucose
Octreotide subcutaneous injection for congenital hyperinsulinemia with ineffective diazine
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
Maintain target blood glucose ≥3.3mmo/L
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start1 Nov 2021
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Hyperinsulinaemic HypoglycaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunxiu Gong, Beijing Children's Hospital
- Investigators
- bingyan cao, doctor, Principal investigator, doctor of Beijing children's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171751
- Sponsor's protocol ID
- octreotide-CHI-2021
- Acronym
- BCH
- Status last verified
- Dec 2021
- First submitted
- 5 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
- ClinicalTrials.gov ID
- NCT05171751
- Acronym / sponsor ID
- BCH / octreotide-CHI-2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.
Detailed description
Octreotide subcutaneous injection is effective and safe in the treatment of congenital hyperinsulinemia in children with inefficacy of diazazine.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with congenital hyperinsulinemia who received octreotide subcutaneous injection after diazazine treatment failed.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide InjectionAlso: glucoseOctreotide subcutaneous injection for congenital hyperinsulinemia with ineffective diazine | Drug | – |
Primary outcome
blood glucose
Time frame: 1 year
Maintain target blood glucose ≥3.3mmo/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bingyan cao, doctor principal investigator
doctor of Beijing children's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hyperinsulinaemic Hypoglycaemia and Octreotide Adverse Reaction, run by Beijing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.