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

August 13, 2012 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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 N, Denmark, 8200
        • Department of Nephrology, Aarhus University Hospital, Skejby
      • Viborg, Denmark, 8800
        • Department of Nephrology, Viborg Regional Hospital

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

Yes

Genders Eligible for Study

All

Description

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

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
ACTIVE_COMPARATOR: Double meal on a HD day
A standardized meal is served 1 h after start of HD and 1 h after end of HD
Dietary supplement: Double meal
A standardized meal is served 1 h after start of HD and 1 h after end of HD.
NO_INTERVENTION: Single meal on a HD day
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).
NO_INTERVENTION: Single meal on a non-HD day
A standardized meal is served 1 h after study start. After the meal participants fast for 9 h.
NO_INTERVENTION: Single meal (healthy controls)
A standardized meal is served 1 h after study start. After the meal participants fast for 9 h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis
At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis
At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start 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, 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
  • Principal Investigator: Mark Reinhard, MD, Department of Nephrology, Aarhus University Hospital, Skejby, Denmark

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

October 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

October 3, 2011

First Posted (ESTIMATE)

October 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 14, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGFHD2-2011

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.

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