Imaging Pituitary ActiVation by Exendin (iPAVE)

Radboud University Medical Center

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Radiation: Ga-68-NODAGA-exendin-4 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03923114

NL67316.091.18

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Patient group with treatment response

Other group

Description:

PET/CT imaging of patients with response to GLP-1 receptor agonist treatment

Treatment:

Radiation: Ga-68-NODAGA-exendin-4 PET/CT

Patient group without treatment response

Other group

Description:

PET/CT imaging of patients with no response to GLP-1 receptor agonist treatment

Treatment:

Radiation: Ga-68-NODAGA-exendin-4 PET/CT