Imaging Pituitary ActiVation by Exendin

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Radiation: Ga-68-NODAGA-exendin-4 PET/CT

• Registration Number: NCT03923114
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-22
• Study Start: 2019-05-23
• Status Verified: 2024-04
• Primary Completion: 2024-04-03
• Study Completion: 2024-04-03
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient group with treatment response	Ga-68-NODAGA-exendin-4 PET/CT	PET/CT imaging of patients with response to GLP-1 receptor agonist treatment
Patient group without treatment response	Ga-68-NODAGA-exendin-4 PET/CT	PET/CT imaging of patients with no response to GLP-1 receptor agonist treatment

Primary Outcome Measures

Name	Time	Method
Pituitary uptake of Ga-68-NODAGA-exendin	1.5 year	Comparison of the pituitary uptake (Bq) of Ga-68-NODAGA-exendin-4 obtained by quantitative analysis

Secondary Outcome Measures

Name	Time	Method
Metabolic status (ACTH)	1.5 year	Assessment of the metabolic status by performing an ACTH assay (mol/l)
Metabolic status (OGTT)	1.5 year	Assessment of the metabolic status by performing an OGTT (mmol/l)

Trial Locations

Locations (1)

Radboud university medical center; 🇳🇱 Nijmegen, Gelderland, Netherlands