search
Back to results

Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Double meal
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Failure, Chronic focused on measuring Dialysis, Protein-energy wasting, Insulin-Like Growth Factor I, Insulin-Like Growth Factor Binding Protein 1, Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

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

Exclusion criteria:

  • 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

Exclusion criteria during the study:

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

Sites / Locations

  • Department of Nephrology, Aarhus University Hospital, Skejby
  • Department of Nephrology, Viborg Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

No Intervention

No Intervention

Arm Label

Double meal on a HD day

Single meal on a HD day

Single meal on a non-HD day

Single meal (healthy controls)

Arm Description

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

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).

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

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

Outcomes

Primary Outcome Measures

Changes in serum Bioactive IGF-I and IGFBP-1 levels during and after hemodialysis
Changes in plasma Interleukin-6 and serum hsCRP levels during and after hemodialysis

Secondary Outcome Measures

Pulse wave analysis (augmentation index (AIx)) during and after hemodialysis
Mineral metabolism (including calcium, phosphate, PTH, and FGF-23 levels) during and after hemodialysis

Full Information

First Posted
September 29, 2011
Last Updated
August 13, 2012
Sponsor
University of Aarhus
search

1. Study Identification

Unique Protocol Identification Number
NCT01446302
Brief Title
Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal
Official Title
Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Studies show that hemodialysis (HD) is a protein catabolic event per se and probably contributes to the high prevalence of protein-energy wasting among HD patients. The muscle catabolic effect of HD is probably caused by loss of amino acids (10-12 grams per dialysis session) and by exacerbation of the inflammatory and hormonal disorders already present. Activation of the immune system during HD has been linked to the contact of blood cells with the dialyzer membrane and to bacterial-derived DNA fragments in the dialysis fluid. An intradialytic increase in interleukin-6 (IL-6) has been shown to correlate with muscle protein catabolism, and because IL-6 continues to increase for 2 hours after HD has ended, there might be a considerable "carry-over effect" to the post-dialytic period. Moreover, HD induces significant changes in the insulin/insulin-like growth factor I (IGF-I) signaling pathways. Plasma insulin is cleared by HD, and the bioactivity of IGF-I is reduced by 50% during a 4-hr maintenance HD due to an up-regulation of IGF-binding protein 1 (IGFBP-1), the only acutely regulated IGFBP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Dialysis, Protein-energy wasting, Insulin-Like Growth Factor I, Insulin-Like Growth Factor Binding Protein 1, Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double meal on a HD day
Arm Type
Active Comparator
Arm Description
A standardized meal is served 1 h after start of HD and 1 h after end of HD
Arm Title
Single meal on a HD day
Arm Type
No Intervention
Arm Description
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).
Arm Title
Single meal on a non-HD day
Arm Type
No Intervention
Arm Description
A standardized meal is served 1 h after study start. After the meal participants fast for 9 h.
Arm Title
Single meal (healthy controls)
Arm Type
No Intervention
Arm Description
A standardized meal is served 1 h after study start. After the meal participants fast for 9 h.
Intervention Type
Dietary Supplement
Intervention Name(s)
Double meal
Intervention Description
A standardized meal is served 1 h after start of HD and 1 h after end of HD.
Primary Outcome Measure Information:
Title
Changes in serum Bioactive IGF-I and IGFBP-1 levels during and after hemodialysis
Time Frame
At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis
Title
Changes in plasma Interleukin-6 and serum hsCRP levels during and after hemodialysis
Time Frame
At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis
Secondary Outcome Measure Information:
Title
Pulse wave analysis (augmentation index (AIx)) during and after hemodialysis
Time Frame
At 1, 2, 3, ,4, 5, 6, 7, 8, 9, and 10 hours after start of hemodialysis
Title
Mineral metabolism (including calcium, phosphate, PTH, and FGF-23 levels) during and after hemodialysis
Time Frame
At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: > 18 years stable maintenance hemodialysis for at least 3 months well-functioning arteriovenous shunts with recirculation less than 5% informed consent Exclusion criteria: 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 Exclusion criteria during the study: myocardial infarction or arrythmia with hemodynamic derangements permanent thrombosis in the arteriovenous (AV) shunt severe infectious disease renal transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Ivarsen, MD, PhD
Organizational Affiliation
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jan Frystyk, MD,PhD,DMSc
Organizational Affiliation
Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bente Jespersen, MD, DMSc
Organizational Affiliation
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jens S Christiansen, MD, DMSc
Organizational Affiliation
Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Else Randers, MD, PhD
Organizational Affiliation
Department of Nephrology, Viborg Regional Hospital, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark Reinhard, MD
Organizational Affiliation
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology, Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Department of Nephrology, Viborg Regional Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal

We'll reach out to this number within 24 hrs