Imaging Pituitary ActiVation by Exendin

Diabetes Mellitus, Type 2 Clinical Trial

— iPAVE  

Official title:

iPAVE - Imaging Pituitary ActiVation by Exendin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923114
• Other study ID #: NL67316.091.18
• Status: Completed
• Phase: N/A
• Start date: May 23, 2019
• Est. completion date: April 3, 2024

Study information

• Verified date: April 2024
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 3, 2024
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Radiation:
• Ga-68-NODAGA-exendin-4 PET/CT
PET/CT imaging after injection with Ga-68-NODAGA-exendin-4

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pituitary uptake of Ga-68-NODAGA-exendin	Comparison of the pituitary uptake (Bq) of Ga-68-NODAGA-exendin-4 obtained by quantitative analysis	1.5 year
Secondary	Metabolic status (OGTT)	Assessment of the metabolic status by performing an OGTT (mmol/l)	1.5 year
Secondary	Metabolic status (ACTH)	Assessment of the metabolic status by performing an ACTH assay (mol/l)	1.5 year