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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01209403
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : September 30, 2011
Information provided by (Responsible Party):
University of Aarhus

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 failure.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Glucose-infusion Drug: Glucose-insulin infusion Phase 4

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). 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
Study Start Date : September 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: No treatment
Active Comparator: Glukose-infusion
Glucose-infusion during hemodialysis
Drug: Glucose-infusion
Continuous iv infusion of glucose
Other Name: Glukose

Active Comparator: Glucose-insulin infusion
Glucose-insulin infusion during hemodialysis
Drug: Glucose-insulin infusion
Continuous iv infusion of glucose and shortlasting
Other Names:
  • Glukose
  • Novorapid

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01209403

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Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200 N
Sponsors and Collaborators
University of Aarhus
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Study Director: Per Ivarsen, MD, PhD Department of Nephrology, Aarhus University Hospital, Skejby
Study Director: Jan Frystyk, MD,PhD,DMSc Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Study Director: Bente Jespersen, MD, DMSc Department of Nephrology, Aarhus University Hospital, Skejby
Principal Investigator: Mark Reinhard, MD Department of Nephrology, Aarhus University Hospital, Skejby

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Aarhus Identifier: NCT01209403    
Other Study ID Numbers: IGFHD1-2010
2010-020114-29 ( EudraCT Number )
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: September 30, 2011
Last Verified: September 2011
Keywords provided by University of Aarhus:
Insulin-Like Growth Factor I
Insulin-Like Growth Factor Binding Protein 1
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action