Clinical Trials Directory

Trials / Completed

CompletedNCT01446302

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTDouble mealA standardized meal is served 1 h after start of HD and 1 h after end of HD.

Timeline

Start date
2011-10-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2011-10-05
Last updated
2012-08-14

Locations

2 sites across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01446302. Inclusion in this directory is not an endorsement.