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Imaging Pituitary ActiVation by Exendin (iPAVE)

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ClinicalTrials.gov Identifier: NCT03923114
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Radboud University

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 Intervention/treatment Phase
Diabetes Mellitus, Type 2 Radiation: Ga-68-NODAGA-exendin-4 PET/CT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : April 26, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
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

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




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)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923114


Contacts
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Contact: Tom Jansen, MSc 0031243667244 tom.jp.jansen@radboudumc.nl
Contact: Marti Boss, MSc 0031243613813 marti.boss@radboudumc.nl

Locations
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Netherlands
Radboud university medical center Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Tom Jansen, MSc    0031243667244    tom.jp.jansen@radboudumc.nl   
Contact: Marti Boss, MSc    0031243613813    marti.boss@radboudumc.nl   
Sponsors and Collaborators
Radboud University

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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: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
exendin
GLP-1 receptor agonist
HPA-axis
Imaging
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists