Current partner codePEPTIDESDE
NCT03923114·Not applicable·INTERVENTIONAL

Imaging Pituitary ActiVation by Exendin

Status

Completed

Phase

Not applicable

Enrollment

20

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

RADIATION

Ga-68-NODAGA-exendin-4 PET/CT

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

Timeline

From registration to results.

  1. First posted

    Apr 22, 2019

  2. Study start

    May 23, 2019

  3. Primary completion

    Apr 3, 2024

  4. Study completion

    Apr 3, 2024

  5. Results posted

    Not reported

  6. Registry updated

    May 22, 2024

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Netherlands. Showing up to 24 locations stored in the fast local snapshot.

Radboud university medical center

Nijmegen, Gelderland, Netherlands

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Exenatide.

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Put the record in context.

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