← Trials/Trial dossier/NCT03768518

GLP-1-CHI

Unknown

GLP-1 Receptor Expression in CHI

The Physiology of Glucagon-like-peptide-1 Espression in Patients With Endogenous Hyperinsulinism: Correlation With Histopathology

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

40

estimated

Study population

Prediabetes / glucose intolerance

Key I/E criterion

Age ≤16

Primary endpoint

Expression and distribution of GLP-1R in pancreas of children with CHI

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03768518
Org study IDNL54275.091.15

Timeline

Milestones

Study start2018-02-07actual
Study first posted2018-12-07actual
Last update posted2018-12-07actual
Primary completion2019-02-01estimated
Study completion2019-02-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Prediabetes / glucose intolerance

Eligibility

Who can enroll

Maximum age16 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

patients (\<16 years) with biochemically proven endogenous congenital hyperinsulinism

Inclusion criteria

Biochemically and clinically proven endogenous congenital hyperinsulinism:
Unresponsive to medical treatment (diazoxide)
Indication for 18F-DOPA PET/CT based on mutation analysis
Standard imaging (18F-DOPA PET/CT) not older than 8 weeks
<16 years old
Informed consent signed by parents or legal guardians of the patient.

Exclusion criteria

Genetically proven diffuse CHI (presenting with a homozygous or compound heterozygous ABCC8/KCNJ11 mutation)
Calculated creatinine clearance below 40 ml/min
Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions based on CT)
Age > 16 years
No signed informed consent

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
1
Other (unclassified)
1

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Comparison of the exendin PET/CT and F-DOPA PET/CT

Time frame:1 year

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Expression and distribution of GLP-1R in pancreas of children with CHI

Time frame:1 year

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.