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Completed

NCT Number: NCT01209403

Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients

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 failure.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inflammation Kidney Diseases Male Urogenital Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Nephrology, Aarhus University Hospital, Skejby

Aarhus, 8200 N, Denmark

About this study

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). Maintenance HD is considered to contribute to the malnutrition of patients with ESRF, but the exact mechanism has remained unknown. However, we have recently shown that the bioactivity of insulin-like growth factor-I (IGF-I) is reduced by 50% during HD. Furthermore, we showed that the reduction in the bioactivity of IGF-I is directly linked to an up-regulation of IGF-binding protein-1 (IGFBP-1), the only acutely regulated IGFBP, which increased by 6-fold during HD. IGFBP-1 is produced in the liver, primarily under the control of insulin, which promptly inhibits the hepatic production of IGFBP-1. As plasma insulin remains fairly low during a maintenance HD, the increase in IGFBP-1 may be explained by the absence of insulin.

The finding that 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 ESRF 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years
  • stable patients on maintenance hemodialysis for > 3 months
  • well-functioning arteriovenous (AV) shunt with recirculation < 5%
  • informed consent

Exclusion criteria

  • 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

Treatment and study plan

Glucose-infusion

Drug

Continuous iv infusion of glucose

Other names: Glukose

Glucose-insulin infusion

Drug

Continuous iv infusion of glucose and shortlasting

Other names: Glukose, Novorapid

Primary outcomes

  1. Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during hemodialysis

    Time frame: From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis

    All patients are randomly assigned to a hemodialysis session with either i) no infusion, ii) a continuous iv infusion of glucose, and iii) a continuous iv infusion of glucose and shortacting insulin. Each dialysis session will be separated by 2 weeks of wash-out

Secondary outcomes

  1. Relationship between inflammatory markers and plasma concentrations of IGF-I and IGFBP-1 during hemodialysis

    Time frame: From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 27, 2010
Registry last updated
Sep 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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