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

NCT ID: NCT01446302

Last Updated: 2012-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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

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Kidney Failure, Chronic

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Double meal on a HD day

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

Group Type ACTIVE_COMPARATOR

Double meal

Intervention Type DIETARY_SUPPLEMENT

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

Single meal on a HD day

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Single meal on a non-HD day

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Single meal (healthy controls)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Double meal

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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


* myocardial infarction or arrythmia with hemodynamic derangements
* permanent thrombosis in the arteriovenous (AV) shunt
* severe infectious disease
* renal transplantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Ivarsen, MD, PhD

Role: STUDY_DIRECTOR

Department of Nephrology, Aarhus University Hospital, Skejby, Denmark

Jan Frystyk, MD,PhD,DMSc

Role: STUDY_DIRECTOR

Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark

Bente Jespersen, MD, DMSc

Role: STUDY_DIRECTOR

Department of Nephrology, Aarhus University Hospital, Skejby, Denmark

Jens S Christiansen, MD, DMSc

Role: STUDY_DIRECTOR

Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark

Else Randers, MD, PhD

Role: STUDY_DIRECTOR

Department of Nephrology, Viborg Regional Hospital, Denmark

Mark Reinhard, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Aarhus University Hospital, Skejby, Denmark

Locations

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Department of Nephrology, Aarhus University Hospital, Skejby

Aarhus N, , Denmark

Site Status

Department of Nephrology, Viborg Regional Hospital

Viborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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IGFHD2-2011

Identifier Type: -

Identifier Source: org_study_id