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Imaging Pituitary ActiVation by Exendin

  • Clinicaltrials.gov identifier

    NCT03923114

  • Recruitment Status

    Recruiting

  • First Posted

    April 22, 2019

  • Last update posted

    October 9, 2020

Study Description

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.

  • Condition or Disease:Diabetes Mellitus, Type 2
  • Intervention/Treatment: Radiation: Ga-68-NODAGA-exendin-4 PET/CT
  • Phase: N/A

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 Design

  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: iPAVE - Imaging Pituitary ActiVation by Exendin
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: February 2021
  • Estimated Study Completion Date: March 2021

Arms and interventions

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

Outcome Measures

  • Primary Outcome Measures: 1. 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
  • Secondary Outcome Measures: 1. Metabolic status (OGTT) [ Time Frame: 1.5 year ]
    Assessment of the metabolic status by performing an OGTT (mmol/l)
  • 2. Metabolic status (ACTH) [ Time Frame: 1.5 year ]
    Assessment of the metabolic status by performing an ACTH assay (mol/l)

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Tom Jansen, MSc 0031243667244 tom.jp.jansen@radboudumc.nl

Contact: Marti Boss, MSc 0031243613813 marti.boss@radboudumc.nl

Locations

Netherlands, Gelderland
Radboud university medical center
Nijmegen

Sponsors and Collaborators

Radboud University

More Information

  • Responsible Party: Radboud University
  • ClinicalTrials.gov Identifier: NCT03923114 History of Changes
  • Other Study ID Numbers: NL67316.091.18
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: October 9, 2020
  • Last Verified: October 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Radboud University: GLP-1 receptor agonist
    HPA-axis
    exendin
    Imaging
  • Additional relevant MeSH terms: Diabetes Mellitus, Type 2