Status:
COMPLETED
Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
Lead Sponsor:
University of Aarhus
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is 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 failur...
Detailed Description
Nutritional markers such as lean body mass and serum albumin are strong predictors of the mortality and morbidity in patients with end-stage renal failure (ESRF) on maintenance hemodialysis (HD). Main...
Eligibility Criteria
Inclusion
- \> 18 years
- stable patients on maintenance hemodialysis for \> 3 months
- well-functioning arteriovenous (AV) shunt with recirculation \< 5%
- informed consent
Exclusion
- diabetes mellitus
- body mass index \< 18.5 kg/m2 or \> 30 kg/m2
- malnutrition (subjective global assessment (SGA) score C)
- malignancy
- use of immunosuppressive drugs including glucocorticosteroids
- severe infectious disease \< 4 weeks
- pregnancy
- Exclusion Criteria during the study:
- myocardial infarction or arrythmia with hemodynamic derangements
- permanent thrombosis in the arteriovenous (AV) shunt
- severe infectious disease
- renal transplantation
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01209403
Start Date
September 1 2010
End Date
July 1 2011
Last Update
September 30 2011
Active Locations (1)
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1
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200 N