Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main goal is the comparison of pituitary uptake of Ga-68-NODAGA-exendin-4 in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.
The prevalence of type 2 diabetes (T2D) is increasing and a better understanding of the mechanisms of T2D becomes increasingly important. The glucagon-like peptide 1 receptor agonists (GLP-1RA), such as exendin, can be used as potent antidiabetic drugs for treatment of T2D. Not all patients with T2D respond to treatment with GLP-1RA and some even respond with contradictory effects, but the underlying mechanism for this observation remains unclear. Interestingly, uptake of an exendin-based radiotracer was observed in the pituitary gland in diabetes patients. In this study, the effect of GLP-1RA on the HPA axis will be further studied for an improved understanding of the mechanisms and contradictory treatment responses.
Patient data will be obtained and will consist of metabolic characterization (laboratory parameters and oral glucose tolerance test), an ACTH assay and determination of cortisol excretion. In addition, Ga-68-NODAGA-exendin-4 PET/CT imaging will be performed in 10 patients with treatment response (decrease in HbA1c or weight loss) and 10 patients without response after GLP-1RA therapy. In 5 patients with high radiotracer uptake, an additional brain MRI scan will be performed for improved anatomical referencing.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient group with treatment response | Other | PET/CT imaging of patients with response to GLP-1 receptor agonist treatment |
|
| Patient group without treatment response | Other | PET/CT imaging of patients with no response to GLP-1 receptor agonist treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68-NODAGA-exendin-4 PET/CT | Radiation | PET/CT imaging after injection with Ga-68-NODAGA-exendin-4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pituitary uptake of Ga-68-NODAGA-exendin | Comparison of the pituitary uptake (Bq) of Ga-68-NODAGA-exendin-4 obtained by quantitative analysis | 1.5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic status (OGTT) | Assessment of the metabolic status by performing an OGTT (mmol/l) | 1.5 year |
| Metabolic status (ACTH) | Assessment of the metabolic status by performing an ACTH assay (mol/l) |
Not provided
Inclusion Criteria:
Patients with treatment response:
Patients without treatment response:
Exclusion Criteria:
Liver disease
Renal disease
Pregnancy or the wish to become pregnant within 6 months after the study
Breastfeeding
Age <18 years
Pituitary disorder
Inability to sign informed consent
Exclusion criteria for MR:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud university medical center | Nijmegen | Gelderland | 6525 GA | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1.5 year |
| D004700 | Endocrine System Diseases |