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

September 29, 2011 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200 N
        • Department of Nephrology, Aarhus University Hospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: No treatment
ACTIVE_COMPARATOR: Glukose-infusion
Glucose-infusion during hemodialysis
Drug: Glucose-infusion
Continuous iv infusion of glucose
Other Names:
  • Glukose
ACTIVE_COMPARATOR: Glucose-insulin infusion
Glucose-insulin infusion during hemodialysis
Drug: Glucose-insulin infusion
Continuous iv infusion of glucose and shortlasting
Other Names:
  • Novorapid
  • Glukose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 24, 2010

First Posted (ESTIMATE)

September 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 30, 2011

Last Update Submitted That Met QC Criteria

September 29, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGFHD1-2010
  • 2010-020114-29 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Failure, Chronic

Clinical Trials on Glucose-infusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe