E10-E14 R73
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: age > 18 years ; Patients with clinically manifest diabetes mellitus (type 1 or 2; diagnosed according to known criteria) ; Subjects with prediabetes (diagnosed with previous oral glucose tolerance tests at screening for other studies where subjects are not included in an interventional study) ; All study participants must be able to understand the information or consent documents provided.
Exclusion criteria
Exclusion criteria: known allergy to iodine-containing contrast media ; thyroid-stimulating hormone (TSH) 38.0°C)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Collection of blood samples to determine cystatin C and creatinine, Injection of 10 ml of an iohexol solution approved for imaging purposes (ACCUPAQUE 240), flushing the venous catheter using 10 ml of commercial NaCl solution, collection of blood samples after 2h, 2,5h, 3h and 3,5h, centrifugation of the samples within 2 hours after collection at 2500 g/min, storage of the centrifuged samples at -20°C, analysis of the iohexol concentration in the samples by means of HCL -> Objective: determine correlation between eGFR (cystatin C and creatinine based) with measured GFR (renal iohexol clearance) 2) Measurement of body composition (muscle/fat percentage, height, weight, etc.) by means of bioimpedance measurement with the Body Composition Monitor (BCM) of Fresenius Medical Care GmbH (Bad Homburg, Germany). -> Correlation between body composition and GFR/eGFR difference? 3) In a subgroup of patients with prediabetes, the eGFR/GFR measurement from 1) is performed during an oral glucose tolerance test (75 g standardized glucose solution). -> Objective: To test the influence of an oral glucose tolerance test on GFR measurement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Concordance of cystatin C-eGFR or iohexol GFR during an oral glucose tolerance test compared with the value without a concurrent oral glucose tolerance test. | — |
Countries
Germany
Contacts
Sektion Nieren- und Hochdruckerkrankungen, Medizinische Klinik, Abteilung IV