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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01446302
First received: September 29, 2011
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Kidney Failure, Chronic
Dietary Supplement: Double meal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446302

Locations
Denmark
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Department of Nephrology, Viborg Regional Hospital
Viborg, Denmark, 8800
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01446302     History of Changes
Other Study ID Numbers: IGFHD2-2011
Study First Received: September 29, 2011
Last Updated: August 13, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Dialysis
Protein-energy wasting
Insulin-Like Growth Factor I
Insulin-Like Growth Factor Binding Protein 1
Inflammation

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014