NCT01209403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 30, 2011

Status Verified

September 1, 2011

Enrollment Period

10 months

First QC Date

September 17, 2010

Last Update Submit

September 29, 2011

Conditions

Kidney Failure, Chronic

Keywords

DialysisMalnutritionInsulin-Like Growth Factor IInsulin-Like Growth Factor Binding Protein 1Inflammation

Outcome Measures

Primary Outcomes (1)

  • Effect of glucose and glucose-insulin infusion on plasma IGF-I and IGFBP-1 during 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 Outcomes (1)

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

    From 2 h prior to start of hemodialysis to 2 h after end of hemodialysis

Study Arms (3)

No treatment

NO INTERVENTION

Glukose-infusion

ACTIVE COMPARATOR

Glucose-infusion during hemodialysis

Drug: Glucose-infusion

Glucose-insulin infusion

ACTIVE COMPARATOR

Glucose-insulin infusion during hemodialysis

Drug: Glucose-insulin infusion

Interventions

Glucose-infusionDRUG

Continuous iv infusion of glucose

Also known as: Glukose
Glukose-infusion
Glucose-insulin infusionDRUG

Continuous iv infusion of glucose and shortlasting

Also known as: Glukose, Novorapid
Glucose-insulin infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology, Aarhus University Hospital, Skejby

Aarhus, 8200 N, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 23557110DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicMalnutritionInflammation

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • 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

    STUDY DIRECTOR

  • Mark Reinhard, MD

    Department of Nephrology, Aarhus University Hospital, Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 27, 2010

Study Start

September 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 30, 2011

Record last verified: 2011-09

Locations

DK(1)