Effect of Gelofusine on GLP1-receptor Imaging

NCT02541734 · Completed

Last updated 2026-05-28

This clinical trial is testing whether Gelofusine affects the imaging results of a diabetes-related scan in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase1, Phase2

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) basic-science study

Participants 12 people

Who can join Ages 18–60 · all sexes Healthy volunteers accepted.

Timeline Started 2015-08 · est. completion 2017-05

What this study is testing ClinicalTrials.gov NCT02541734 ↗

Description as written by the study sponsor.

The highly promising and innovative tracer on 111In-DTPA-AHX-Lys40-Exendin 4 has been applied to determine beta cell mass in healthy volunteers and patients with type 1 diabetes. However, the high retention of the tracer in the kidneys was leading to a kidney/pancreas uptake ratio of 41±23. This high renal uptake is complicating absolute BCM quantification by SPECT imaging. In order to reduce the kidney/pancreas uptake ratio, investigators propose a co-infusion with the plasma expander Gelofusine since it has been shown in several pre-clinical and clinical studies that Gelofusine can reduce the renal retention of several other, closely related tracers. When investigators are able to reduce the kidney/pancreas uptake ratio, these findings will improve the interpretation of clinical quantitative SPECT, having important implications for therapeutic decision making for patients with diabetes, insulinomas or congenital hyperinsulinism, and may also have a major impact on our understanding of the pathophysiology of these diseases.

Treatments tested

Gelofusine Drug

Infusion of gelofusine
111In-exendin 4 SPECT/CT Radiation

111In-exendin 4 SPECT/CT
Placebo Drug

Main thing measured	Renal uptake as measured by uptake of 111In-exendin-4 on SPECT images and without co-infusion of Gelofusine.
Sponsor	Radboud University Medical Center
Conditions studied	Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02541734 ↗