Kidney Failure, ChronicNCT01446302
Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal
A study testing Double meal in people with Kidney Failure, Chronic, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Double meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years
- stable maintenance hemodialysis for at least 3 months
- well-functioning arteriovenous shunts with recirculation less than 5%
- informed consent
Who cannot join
- 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)
Show all 11Show fewer
- pregnancy
- myocardial infarction or arrythmia with hemodynamic derangements
- permanent thrombosis in the arteriovenous (AV) shunt
- severe infectious disease
- renal transplantation
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus N, 8200
Department of Nephrology, Viborg Regional Hospital
Viborg, 8800
About this study
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.
Read the 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
- Kidney Failure, Chronic
- Being tested
- Double meal
- Keywords
- Dialysis, Protein-energy wasting, Insulin-Like Growth Factor I, Insulin-Like Growth Factor Binding Protein 1, Inflammation
- Medical subject headings
- Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double mealDietary supplement
A standardized meal is served 1 h after start of HD and 1 h after end of HD.
| Study group | Role | What they receive |
|---|---|---|
| Double meal on a HD day | Active comparator | A standardized meal is served 1 h after start of HD and 1 h after end of HD Receives: Dietary Supplement: Double meal |
| Single meal on a HD day | No intervention | 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 | A standardized meal is served 1 h after study start. After the meal participants fast for 9 h. |
| Single meal (healthy controls) | No intervention | A standardized meal is served 1 h after study start. After the meal participants fast for 9 h. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum Bioactive IGF-I and IGFBP-1 levels during and after hemodialysis
Measured: 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
Measured: At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis
Secondary outcomes (2)
Pulse wave analysis (augmentation index (AIx)) during and after hemodialysis
Measured: 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
Measured: At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Ivarsen, MD, PhD, Study director, Department of Nephrology, Aarhus University Hospital, Skejby, DenmarkJan Frystyk, MD,PhD,DMSc, Study director, Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, DenmarkBente Jespersen, MD, DMSc, Study director, Department of Nephrology, Aarhus University Hospital, Skejby, DenmarkJens S Christiansen, MD, DMSc, Study director, Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, DenmarkElse Randers, MD, PhD, Study director, Department of Nephrology, Viborg Regional Hospital, DenmarkMark Reinhard, MD, Principal investigator, Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446302
- Sponsor's protocol ID
- IGFHD2-2011
- Status last verified
- Aug 2012
- First submitted
- 29 Sep 2011
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Inflammatory Responses to Hemodialysis and the Effect of a Meal
- ClinicalTrials.gov ID
- NCT01446302
- Acronym / sponsor ID
- IGFHD2-2011
- Conditions
- Kidney Failure, Chronic
- Keywords
- Dialysis, Protein-energy wasting, Insulin-Like Growth Factor I, Insulin-Like Growth Factor Binding Protein 1, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Double meal on a HD day | Active comparator | Dietary Supplement: Double mealA standardized meal is served 1 h after start of HD and 1 h after end of HD |
| Single meal on a HD day | No intervention | –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 | –A standardized meal is served 1 h after study start. After the meal participants fast for 9 h. |
| Single meal (healthy controls) | No intervention | –A standardized meal is served 1 h after study start. After the meal participants fast for 9 h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years
- stable maintenance hemodialysis for at least 3 months
- well-functioning arteriovenous shunts with recirculation less than 5%
- informed consent
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double mealA standardized meal is served 1 h after start of HD and 1 h after end of HD. | Dietary supplement | Double meal on a HD day |
Primary outcome
Changes in serum Bioactive IGF-I and IGFBP-1 levels during and after hemodialysis
Time frame: 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
Time frame: At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis
2 secondary outcomes
Pulse wave analysis (augmentation index (AIx)) during and after hemodialysis
Time frame: 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
Time frame: At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Ivarsen, MD, PhD study director
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
Jan Frystyk, MD,PhD,DMSc study director
Department of Endocrinology and Internal Medicine & Medical Research Laboratories, Clinical Institute, Aarhus University Hospital, Denmark
Bente Jespersen, MD, DMSc study director
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double meal in people with Kidney Failure, Chronic, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum Bioactive IGF-I and IGFBP-1 levels during and after hemodialysis (time frame: At 1, 2, 3, 5, 6, 7, 9, and 10 hours after start of hemodialysis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.