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

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Dietary Supplement: Double meal

• Registration Number: NCT01446302
• Lead Sponsor: University of Aarhus

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2011-09-29
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-03
• Study First Posted: 2011-10-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-13
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Double meal on a HD day	Double meal	A standardized meal is served 1 h after start of HD and 1 h after end of HD

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Department of Nephrology, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark

Department of Nephrology, Viborg Regional Hospital; 🇩🇰 Viborg, Denmark