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Completed

NCT Number: NCT01446302

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double meal

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2011
Registry last updated
Aug 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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