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

NCT ID: NCT01209403

Last Updated: 2011-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Failure, Chronic

Keywords

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Dialysis Malnutrition Insulin-Like Growth Factor I Insulin-Like Growth Factor Binding Protein 1 Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Glukose-infusion

Glucose-infusion during hemodialysis

Group Type ACTIVE_COMPARATOR

Glucose-infusion

Intervention Type DRUG

Continuous iv infusion of glucose

Glucose-insulin infusion

Glucose-insulin infusion during hemodialysis

Group Type ACTIVE_COMPARATOR

Glucose-insulin infusion

Intervention Type DRUG

Continuous iv infusion of glucose and shortlasting

Interventions

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Glucose-infusion

Continuous iv infusion of glucose

Intervention Type DRUG

Glucose-insulin infusion

Continuous iv infusion of glucose and shortlasting

Intervention Type DRUG

Other Intervention Names

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Glukose Glukose Novorapid

Eligibility Criteria

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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


* myocardial infarction or arrythmia with hemodynamic derangements
* permanent thrombosis in the arteriovenous (AV) shunt
* severe infectious disease
* renal transplantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Ivarsen, MD, PhD

Role: STUDY_DIRECTOR

Department of Nephrology, Aarhus University Hospital, Skejby

Jan Frystyk, MD,PhD,DMSc

Role: STUDY_DIRECTOR

Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Bente Jespersen, MD, DMSc

Role: STUDY_DIRECTOR

Department of Nephrology, Aarhus University Hospital, Skejby

Mark Reinhard, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Aarhus University Hospital, Skejby

Locations

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Department of Nephrology, Aarhus University Hospital, Skejby

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Reinhard M, Frystyk J, Jespersen B, Bjerre M, Christiansen JS, Flyvbjerg A, Ivarsen P. Effect of hyperinsulinemia during hemodialysis on the insulin-like growth factor system and inflammatory biomarkers: a randomized open-label crossover study. BMC Nephrol. 2013 Apr 4;14:80. doi: 10.1186/1471-2369-14-80.

Reference Type DERIVED
PMID: 23557110 (View on PubMed)

Other Identifiers

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2010-020114-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IGFHD1-2010

Identifier Type: -

Identifier Source: org_study_id