The purpose of this study is to investigate the correlation between HbA1c and iron status in Type 2 Diabetes mellitus patients with iron deficiency by intravenous substitution of iron.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
152
Dose:according to SmPC Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
Gemeinschaftspraxis Dres. Grüneberg, Mehring, Stude
Herne, North Rhine-Westphalia, Germany
Univesitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany
Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum
Bad Oeynhausen, Germany
Studienzentrum Professor Hanefeld Abakus Büropark
Dresden, Germany
reduction in HBA1c-levels
reduction of HbA1c from week 1 (baseline) to week 13
Time frame: 12 weeks
improvement of haematological and iron status
Hb, MCV, MCH, hypochromic cells, reticulocyte Hb content, ferritin, transferrin, transferrin saturation (TSAT), sTFR, iron, hepcidin
Time frame: 12 weeks
improvement in quality of life
potential clinical improvement and improvement in quality of life (EQ5D) of patients with ID T2DM
Time frame: 12 weeks
Improvement of metabolic status
measurement of fasting glucose, fructosamine
Time frame: 12 weeks
reliability of HbA1c-measurements
measurement of HbA1c in week 0; 5 and 13
Time frame: 12 weeks
improvement in vascular function
Improvement in vascular function on the basis of the biomarker ADMA serum level
Time frame: 12 weeks
Change in used insulin dosage during study
Change in used insulin dosage during study (via patient diary)
Time frame: 12 weeks
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Medizinische Hochschule Hannover Klinisches Forschungszentrum CRC
Hanover, Germany
Diabetesinstitut Heidelberg
Heidelberg, Germany