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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01446302
Enrollment
24
Registered
2011-10-05
Start date
2011-10-31
Completion date
2012-05-31
Last updated
2012-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Keywords

Dialysis, Protein-energy wasting, Insulin-Like Growth Factor I, Insulin-Like Growth Factor Binding Protein 1, Inflammation

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.

Interventions

DIETARY_SUPPLEMENTDouble meal

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

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Changes in serum Bioactive IGF-I and IGFBP-1 levels during and after hemodialysisAt 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 hemodialysisAt 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis

Secondary

MeasureTime frame
Pulse wave analysis (augmentation index (AIx)) during and after hemodialysisAt 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 hemodialysisAt 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026