RADIATION
Ga-68-NODAGA-exendin-4 PET/CT
PET/CT imaging after injection with Ga-68-NODAGA-exendin-4
Status
Completed
Phase
Not applicable
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
RADIATION
PET/CT imaging after injection with Ga-68-NODAGA-exendin-4
Timeline
First posted
Apr 22, 2019
Study start
May 23, 2019
Primary completion
Apr 3, 2024
Study completion
Apr 3, 2024
Results posted
Not reported
Registry updated
May 22, 2024
Outcomes
Pituitary uptake of Ga-68-NODAGA-exendin
Time frame · 1.5 year
Comparison of the pituitary uptake (Bq) of Ga-68-NODAGA-exendin-4 obtained by quantitative analysis
Metabolic status (OGTT)
Time frame · 1.5 year
Assessment of the metabolic status by performing an OGTT (mmol/l)
Metabolic status (ACTH)
Time frame · 1.5 year
Assessment of the metabolic status by performing an ACTH assay (mol/l)
Eligibility
Inclusion Criteria: Patients with treatment response: * Age ≥18 years * Subject is diagnosed with type 2 diabetes * Subject showed response to GLP-1RA treatment * Ability to sign informed consent Patients without treatment response: * Age ≥18 years * Subject is diagnosed with type 2 diabetes * Subject showed no response to GLP-1RA treatment * Ability to sign informed consent 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: * Fragments, clips or devices in brain, eyes, spinal canal * Implantable defibrillator or pacemaker (wires) * Mandibular magnetic implants * Neurostimulator, bladder stimulator, non-removable insulin pump * Metal tissue-expander in chest * Cochlear implant * Ossicular replacement prosthesis
Study locations
Netherlands. Showing up to 24 locations stored in the fast local snapshot.
Radboud university medical center
Nijmegen, Gelderland, Netherlands
Publications
No PMID-linked publications were present in this registry snapshot.
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