Imaging Pituitary ActiVation by Exendin (iPAVE)

May 21, 2024 updated by: Radboud University Medical Center

iPAVE - Imaging Pituitary ActiVation by Exendin

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient group with treatment response
PET/CT imaging of patients with response to GLP-1 receptor agonist treatment
Radiation: Ga-68-NODAGA-exendin-4 PET/CT
PET/CT imaging after injection with Ga-68-NODAGA-exendin-4
Other: Patient group without treatment response
PET/CT imaging of patients with no response to GLP-1 receptor agonist treatment
Radiation: Ga-68-NODAGA-exendin-4 PET/CT
PET/CT imaging after injection with Ga-68-NODAGA-exendin-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic status (OGTT)
Time Frame: 1.5 year
Assessment of the metabolic status by performing an OGTT (mmol/l)
1.5 year
Metabolic status (ACTH)
Time Frame: 1.5 year
Assessment of the metabolic status by performing an ACTH assay (mol/l)
1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2019

Primary Completion (Actual)

April 3, 2024

Study Completion (Actual)

April 3, 2024

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL67316.091.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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