Effects of treatment with GLP-1 receptor agonists on the HPA-axis in type 2 diabetes

iPAVE – imaging Pituitary ActiVation by Exendin - GLP1-hypophysis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003566-13-NL

Enrollment

Registered

2018-10-17

Start date

2019-01-02

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Trade Name: Byetta Product Name: 68Ga-NODAGA-[K40]-Exendin-4 Pharmaceutical Form: Radiopharmaceutical precursor, solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria (patients with treatment response) - Age =18 years - Subject is diagnosed with type 2 diabetes - Subject showed response to GLP-1RA treatment (decrease in HbA1c =5 mmol/mol and/or weight loss =5%) - Ability to sign informed consent Inclusion criteria (patients without treatment response) - Age =18 years - Subject is diagnosed with type 2 diabetes - Subject showed no response to GLP-1RA treatment (decrease in HbA1c =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: - Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of the normal range - Renal disease defined as MDRD <40 ml/min/1.73 m^2 - Pregnancy or the wish to become pregnant within 6 months after the study - Breastfeeding - Age <18 years - Pituitary disorder - lnability to sign informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The main study parameter is the comparison of pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.;Secondary Objective: To assess the metabolic status of the patients by obtaining laboratory parameters, oral glucose tolerance testing, stimulated ACTH assay and urinary cortisol excretion tests.;Primary end point(s): The main study parameter is the comparison of pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.;Timepoint(s) of evaluation of this end point: 1.5 hour after the administration of the tracer	—

Measure

Time frame

Main Objective: The main study parameter is the comparison of pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.;Secondary Objective: To assess the metabolic status of the patients by obtaining laboratory parameters, oral glucose tolerance testing, stimulated ACTH assay and urinary cortisol excretion tests.;Primary end point(s): The main study parameter is the comparison of pituitary uptake of 68Ga-NODAGA-exendin in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.;Timepoint(s) of evaluation of this end point: 1.5 hour after the administration of the tracer

—

Secondary

Measure	Time frame
Secondary end point(s): To assess the metabolic status of the patients by obtaining laboratory parameters, oral glucose tolerance testing, stimulated ACTH assay and urinary cortisol excretion tests.;Timepoint(s) of evaluation of this end point: After the analysis of all tests and PET/CT scan	—

Countries

Netherlands

Contacts

Public ContactDepartment of Nuclear Medicine

Radboud university medical center

tom.jp.jansen@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026