This project aims to investigate whether the anabolic potentials of insulin may be used to reverse the catabolic effects of hemodialysis in non-diabetic patients with end-stage renal failure. Thus, the project explores a potentially novel indication for insulin treatment of non-diabetic patients. MedDRA version: 12.1 Level: LLT Classification code 10014647 Term: End stage renal failure
Conditions
Interventions
Trade Name: NovoRapid
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Trade Name: Glucose 10 % "SAD"
Pharmaceutical Form: Intravenous infusion
Sponsors
Department of Nephrology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: age more than 18 years and stable, long-term maintenance hemodialysis. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: diabetes mellitus, pregnancy, body mass index 30 kg/m2, malignancy and the use of immunosuppressive drugs including glucocorticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To characterize changes in inflammatory markers during and after a hemodialysis session and to see if inflammatory changes correlates with changes in IGF-I and IGFBP-1.;Primary end point(s): We have planned a series of proof-of-concept experiments, which are aiming to investigate whether it is possible to suppress the increase in IGFBP-1 and consequently, the reduction in bioactive IGF-I during a scheduled maintenance HD session in non-diabetic ESRF patients.;Main Objective: The finding that hemodialysis (HD) acutely down-regulates the bioactivity of IGF-I by an up-regulation of IGFBP-1 may not only explain the catabolic mechanisms of HD per se, it also opens for a new treatment strategy of end-stage renal failure patients undergoing maintenance HD. Thus, on the basis of our previous study we hypothesize that treatment of ERSF patients with high doses of insulin during maintenance HD may counter-act the HD-induced stimulation of IGFBP-1, making it possible to preserve the bioactivity of IGF-I, and thereby abolishing the catabolic impact of HD. | — |
Countries
Denmark
Outcome results
None listed