NCT01446302

Brief Summary

The objective of this study is to characterize the hormonal and inflammatory responses to hemodialysis, and to determine the effect of a meal versus fast on the metabolic changes in the post-dialytic phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

September 29, 2011

Last Update Submit

August 13, 2012

Conditions

Kidney Failure, Chronic

Keywords

DialysisProtein-energy wastingInsulin-Like Growth Factor IInsulin-Like Growth Factor Binding Protein 1Inflammation

Outcome Measures

Primary Outcomes (2)

  • Changes in serum Bioactive IGF-I and IGFBP-1 levels during and after hemodialysis

    At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis

  • Changes in plasma Interleukin-6 and serum hsCRP levels during and after hemodialysis

    At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis

Secondary Outcomes (2)

  • Pulse wave analysis (augmentation index (AIx)) during and after hemodialysis

    At 1, 2, 3, ,4, 5, 6, 7, 8, 9, and 10 hours after start of hemodialysis

  • Mineral metabolism (including calcium, phosphate, PTH, and FGF-23 levels) during and after hemodialysis

    At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis

Study Arms (4)

Double meal on a HD day

ACTIVE COMPARATOR

A standardized meal is served 1 h after start of HD and 1 h after end of HD

Dietary Supplement: Double meal

Single meal on a HD day

NO INTERVENTION

A standardized meal is served 1 h after start of HD. After the meal participants fast for 9 h (6 h after end of HD).

Single meal on a non-HD day

NO INTERVENTION

A standardized meal is served 1 h after study start. After the meal participants fast for 9 h.

Single meal (healthy controls)

NO INTERVENTION

A standardized meal is served 1 h after study start. After the meal participants fast for 9 h.

Interventions

Double mealDIETARY_SUPPLEMENT

A standardized meal is served 1 h after start of HD and 1 h after end of HD.

Double meal on a HD day

Eligibility Criteria

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

You may qualify if:

  • \> 18 years
  • stable maintenance hemodialysis for at least 3 months
  • well-functioning arteriovenous shunts with recirculation less than 5%
  • informed consent

You may not qualify if:

  • diabetes mellitus
  • body mass index below 18.5 or above 30.0 kg/m2
  • malnutrition (global assessment score C)
  • active malignant disease
  • immunosuppressive treatment (including glucocorticoid treatment)
  • evidence of an ongoing inflammatory disease (including infection and autoimmune disorders)
  • 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 (2)

Department of Nephrology, Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

Department of Nephrology, Viborg Regional Hospital

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Kidney Failure, ChronicInflammation

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 Symptoms

Study Officials

  • Per Ivarsen, MD, PhD

    Department of Nephrology, Aarhus University Hospital, Skejby, Denmark

    STUDY DIRECTOR

  • Jan Frystyk, MD,PhD,DMSc

    Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark

    STUDY DIRECTOR

  • Bente Jespersen, MD, DMSc

    Department of Nephrology, Aarhus University Hospital, Skejby, Denmark

    STUDY DIRECTOR

  • Jens S Christiansen, MD, DMSc

    Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark

    STUDY DIRECTOR

  • Else Randers, MD, PhD

    Department of Nephrology, Viborg Regional Hospital, Denmark

    STUDY DIRECTOR

  • Mark Reinhard, MD

    Department of Nephrology, Aarhus University Hospital, Skejby, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 5, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

DK(2)