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Estimated glomerular filtration rate based on cystatin C in patients with diabetes and prediabetes

Estimated glomerular filtration rate based on cystatin C in patients with diabetes and prediabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028843
Enrollment
100
Registered
2022-04-26
Start date
2022-04-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10-E14 R73

Interventions

Group 1: We measure renal function in patients with diabetes/prediabetes using iohexol clearance and compare it to the estimated renal function (cystatin C, creatinine).

Sponsors

Universitätsklinikum Tübingen Medizinische Klinik, Abteilung IV Sektion Nieren- und Hochdruckerkrankungen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Public ContactFelix Eisinger

Sektion Nieren- und Hochdruckerkrankungen, Medizinische Klinik, Abteilung IV

felix.eisinger@med.uni-tuebingen.de+49 7071-29 82711

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026