Determination of the effect of Gelofusine on the kidney uptake of a radioactive tracer molecule used for imaging of insulin producing beta-cells in the pancreas

Conditions: The aim of this study is to reduce the kidney uptake during 111In-DTPA- exendin4 imaging, a promising and valuable tool for beta-cell mass imaging and quantification, which can be applied in patients with e.g. diabetes.
MedDRA version: 17.1Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 17.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 17.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 17.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Registration Number: EUCTR2014-003006-33-NL

Lead Sponsor: Radboud University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria
• >= 18 years
• <= 60 years
• Normal renal function (creatinine clearance > 90mL/min according to the formula of Cockroft and Gault)
• Normal glucose regulation (HbA1c 53 /mol (7%))
• BMI 17>30
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of any medication affecting renal function
•Known hypersensitivity to one of the substances used
•Hypertension
•Oedema
•Hypervolaemia
•Heart failure
•Pregnancy or the wish to become pregnant within 3 months after participation of the study.
•Lactation
•History of anaphylaxis
•Liver disease defined as aspartate aminotransferase or alanine aminotransferase level more than 3 times the upper limit of normal range (45U/L)
•History of pancreatitis