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

University of Aarhus

Status: Completed

Conditions: Kidney Failure, Chronic

Treatments: Dietary Supplement: Double meal

Study type: Interventional

Funder types: Other

Identifiers

NCT01446302

IGFHD2-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Double meal on a HD day

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Double meal

Single meal on a HD day

No Intervention group

Description:

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).

Single meal on a non-HD day

No Intervention group

Description:

A standardized meal is served 1 h after study start. After the meal participants fast for 9 h.

Single meal (healthy controls)

No Intervention group

Description:

A standardized meal is served 1 h after study start. After the meal participants fast for 9 h.