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

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446302
• Other study ID #: IGFHD2-2011
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: August 13, 2012
• Start date: October 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Dietary Supplement:
• Double meal
A standardized meal is served 1 h after start of HD and 1 h after end of HD.

Locations

Country	Name	City	State
Denmark	Department of Nephrology, Aarhus University Hospital, Skejby	Aarhus N
Denmark	Department of Nephrology, Viborg Regional Hospital	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No