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出境医 / 临床实验 / Imaging Pituitary ActiVation by Exendin (iPAVE)

Imaging Pituitary ActiVation by Exendin (iPAVE)

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 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.

Study Design
Layout table for study information
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
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : March 1, 2021
Arms and Interventions
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
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
Layout table for eligibility information
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
Layout table for location contacts
Contact: Tom Jansen, MSc 0031243667244 tom.jp.jansen@radboudumc.nl
Contact: Marti Boss, MSc 0031243613813 marti.boss@radboudumc.nl

Locations
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE May 23, 2019
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • Metabolic status (OGTT) [ Time Frame: 1.5 year ]
    Assessment of the metabolic status by performing an OGTT (mmol/l)
  • Metabolic status (ACTH) [ Time Frame: 1.5 year ]
    Assessment of the metabolic status by performing an ACTH assay (mol/l)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imaging Pituitary ActiVation by Exendin
Official Title  ICMJE iPAVE - Imaging Pituitary ActiVation by Exendin
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Radiation: Ga-68-NODAGA-exendin-4 PET/CT
PET/CT imaging after injection with Ga-68-NODAGA-exendin-4
Study Arms  ICMJE
  • Patient group with treatment response
    PET/CT imaging of patients with response to GLP-1 receptor agonist treatment
    Intervention: Radiation: Ga-68-NODAGA-exendin-4 PET/CT
  • Patient group without treatment response
    PET/CT imaging of patients with no response to GLP-1 receptor agonist treatment
    Intervention: Radiation: Ga-68-NODAGA-exendin-4 PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tom Jansen, MSc 0031243667244 tom.jp.jansen@radboudumc.nl
Contact: Marti Boss, MSc 0031243613813 marti.boss@radboudumc.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923114
Other Study ID Numbers  ICMJE NL67316.091.18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Radboud University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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