iPAVE - imaging Pituitary ActiVation by Exendi

Phase 2

Recruiting

Conditions: diabetes
type 2 diabetes
10018424

Registration Number: NL-OMON52961

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Inclusion criteria (patients with treatment response)
- Age >=18 years
- Subject is diagnosed with type 2 diabetes
- Subject showed response to GLP-1RA treatment (decrease in HbA1c >=5 mmol/mol
and/or weight loss >=5%)
- Ability to sign informed consent, Inclusion criteria (patients without
treatment response)
- Age >=18 years
- Subject is diagnosed with type 2 diabetes
- Subject showed no response to GLP-1RA treatment as classified by the treating
diabetologist
- Ability to sign informed consent

Exclusion Criteria

- Liver disease defined as aspartate aminotransferase or alanine
aminotransferase level of more than three times the upper limit of the normal
range
- Renal disease defined as MDRD <40 ml/min/1.73 m^2
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
- Age <18 years
- Pituitary disorder
- lnability 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 & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the comparison of pituitary uptake of<br /><br>68Ga-NODAGA-exendin in patients with and without adequate response (based on<br /><br>HbA1c or weight loss or classification by the treating diabetologist) to GLP-1R<br /><br>agonist treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the metabolic status of the patients by obtaining laboratory<br /><br>parameters, oral glucose tolerance testing, stimulated ACTH assay and urinary<br /><br>cortisol excretion tests</p><br>