Effect of Gelofusine on 111In-DTPA-AHX-Lys40-Exendin 4 uptake in the kidney
Phase 2
Completed
- Conditions
- Diabetes10018424
- Registration Number
- NL-OMON41060
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
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
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)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the renal uptake of 111In-DTPA-[K40]-Exendin 4<br /><br>based on quantitative SPECT imaging with and without co-infusion of Gelofusine. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameter is the pancreatic uptake of<br /><br>111In-DTPA-[K40]-Exendin 4 based on quantitative SPECT imaging with and without<br /><br>co-infusion of Gelofusine. </p><br>