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UndernutritionNCT02320552

Prevalence of Protein-energy Wasting and Obesity Among Danish Dialysis Patients

An observational study of Undernutrition and Renal Insufficiency, Chronic, run by Zealand University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the prevalence of protein-energy wasting and obesity among Danish dialysis patients. Read more about this study

Who is it for?
Ages 18 years and older
How many people
105 participants
Where
No sites listed yet
Study dates
Feb 2014to Jun 2017
Phase
Observational
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients receiving regular dialysis therapy at Roskilde Hospital, Denmark in February to June 2014.

Who may be able to join

  • all dialysis patients receiving dialysis therapy at Roskilde Hospital, Denmark

Who cannot join

  • < 3 months dialysis
  • fever
  • antibiotic treatment
  • major surgery within 2 weeks
  • disseminated cancer
  • age below 18
Show all 10Show fewer
  • psychosis
  • pregnancy
  • physical or mental disability where participation was not feasible,
  • language barriers

About this study

The purpose of this study is to determine the prevalence of protein-energy wasting and obesity among Danish dialysis patients.

Read the detailed description

Undernutrition among dialysis patients is associated with increased morbidity and mortality.

Conversely, in hemodialysis (HD) patients a high BMI in the range of obesity has long been known protective against death and cardiovascular disease, a phenomenon called reverse epidemiology. Hence, what is good for the background population might differ from what is good for HD patients.

In peritoneal dialysis (PD) patients this association is less clear. The majority of studies find reverse epidemiology, however some studies find no survival advantage of obesity or even indicate a higher risk of death in obese patients. Some authors claim that reverse epidemiology is a misconception and that although in the short run a high BMI is protective a follow up period of more than five years show increased mortality. Considering this Mutsert et al. claim that HD patients have the same mortality risk patterns associated with BMI as the general population.

Moreover, it has been shown that the protective effect of a high BMI or weight gain is limited to those with normal or high muscle mass. Patients with high BMI and malnutrition have a high risk of death. Concordantly, recent studies show that abdominal obesity is associated with mortality among dialysis patients .

The prevalence of under-nutrition, often known as protein energy wasting (PEW), among dialysis patients varies from 31% to 51% and the prevalence of obesity varies from 10-56% presumably depending on the diagnostic criteria and the method used. These inconsistent results make comparison of the prevalence of undernutrition and obesity among dialysis populations somewhat problematic.

In order to standardize the diagnosis of PEW in dialysis patients International Society of Renal Nutrition and Metabolism (ISRNM) suggest diagnostic criteria. As goes for obesity, there are no standardized methods for diagnosing this among dialysis patients. However, reviews recommend using multiple different methods concurrently including BMI, fat percentage (FM%), and measures of abdominal fat.

Data on the nutritional status among dialysis patients in Northern Europe are primary derived from a single research center (Karolinska institute, Sweden) and there is no recent published data on the prevalence of PEW among dialysis patients. A single study examines the prevalence of obesity.

Few studies have compared the nutritional status of HD and PD patients. Hardly any studies examine the prevalence of undernutrition and obesity in the same population.

Knowing the nutritional status of a dialysis population and identifying already malnourished patients, can contribute the quality of the care provided.

Hence, the aim of this study is, for the first time in Northern Europe to assess the prevalence of both PEW and obesity in the same population using the ISRNM criteria as well as different obesity markers. Additionally, we compare the nutritional status of HD and PD patients.

Design The study was designed as a cross-sectional study, investigating the nutritional status of hemodialysis (HD) patients and peritoneal dialysis (PD) patients attending the dialysis centre at Roskilde Hospital, Denmark in February to June 2014.

Subjects All PD, HD and home-HD patients (n = 105) were invited to participate. Patients who refused to participate were invited to complete a partial nutritional examination. The participating eligible patients all gave their written consent. Patient data (age, gender, dialysis vintage, primary kidney disease and co morbid conditions were taken from the patient records. The local ethical committee approved the study protocol.

Anthropometric measurements Anthropometric measurements were performed immediately after a dialysis session (HD) as recommended by the HEMO study or after the monthly ambulatory control (PD, home-HD). All measurements were done on the non-access side of the body for HD-patients and on the right side for PD-patients. Skin folds (SF) were measured with a Harpenden caliper and all circumferences were done using a non-stretchable fiberglass insertion tape (seca 201). All measurements were made by to well-trained research assistants.

Height (h) and bodyweight (BW) was measured in light clothing using standard instrument in the dialysis centre. For PD the weighing was preferably done with empty abdominal cavity, for those (n=8) who refused to empty the abdominal cavity the bodyweight was calculated as BW with dialysate minus the volume of dialysate that was last drained into the abdomen. For patients with lower leg amputations (n=2) 6.2% of total bodyweight per amputated leg was added to the measured weight

Fat mass was assessed according to a formula described by Durnin and Womersley based on four skinfold thicknesses (biceps, triceps, subscapular and suprailiac). Mid-arm circumference (MAC) was measured midway between acromion and olecranon. All measurements were done in duplicate. If the two measurements were more than four mm apart, two additional measurements were done and the mean of all four was calculated. This approach is recommended by "CLINICAL PRACTICE GUIDELINES For Nutrition of Chronic Renal Failure". Triceps skinfold (TSF) and MAC was used to calculate corrected mid-arm muscle area (cMAMA) as described by Heymsfield SB et al.

Waist circumference (WC) was measured as recommended by WHO. Patients unable to stand had their waist and hip circumference measurement done in supine position. The waist and hip measurements were skipped if empty abdominal cavity was not feasible for PD patients. All measurements were done in duplicate if the difference between the two measurements exceeded 1 cm, two more measurements were done, and the mean of all four calculated.

Lean body mass index (LBMI) and fat mass index (FMI) was calculated as lean body mass (LBM)/h2 and fat mass (FM)/h2 respectively as described by Kyle et al.

Blood sampling and biochemical measurements For assessment of s-transferrin and albumin blood samples were from all patients was analyzed at the laboratory at Roskilde Sygehus, Denmark. Kt/V was measured as described by F.A.Gotch(Gotch 1998). For HD-patients normalized protein catabolic rate (nPCR) was determined by measuring the interdialytic rise of blood urea nitrogen after a midweek dialysis session. For patients with residual urine output > 300ml/day urinary nitrogen excretion was also taken into account. To account for day-to-day variations we calculated a mean of three nPCR measurements, which were made over a 2 months period after the anthropometric measurements, we only made one urine sample. For PD-patients nPCR was measured using the Bergstroms' formula. Only one nPCR measurement was done for PD patients

Being tested
No intervention
Keywords
Nutritional assessment
Medical subject headings
Malnutrition, Renal Insufficiency, Chronic, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    no intervention

Study groups in NCT02320552
Study groupRoleWhat they receive
PD patientsPatients receiving peritoneal dialysis. No intervention
Receives: Other: No intervention
HD patientsPatients receiving hemodialysis. No intervention
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Undernutrition

    Classification of undernutrition Undernutrition was assessed 3 different methods: 1) WHO cut-off of BMI < 18,5kg/m2, 2) the criteria for protein-energy wasting (PEW) defined by the International Society of Renal Nutrition and Metabolism (ISRNM) and 3) our own criteria for PEW based on fat mass index (FMI) and a lean body mass index (LBMI).

    According to ISRNM, PEW is present if at least one abnormal measure is recorded is in at least three of the four categories. We measured the four markers: albumin, BMI, corrected mid-arm muscle area (cMAMA) and normalized protein catabolic rate (nPCR) (a measure of daily protein intake (DPI)).

    Classification of under nutrition BMI < 18,5kg/m2 FMI<10th percentile and LBMI <10th percentile

    PEW 3 of 4:

    • Serum albumin < 38g/L
    • BMI < 23
    • cMAMA reduction >10% in relation to 50th percentile of reference population
    • Unintentional low DPI < 0,8g/kg/d

    Measured: 3 months

Secondary outcomes (1)
  1. Obesity

    As recommended by Zoccali et al obesity was assessed using different criteria based on either BMI, fat percentage (FM%), waist circumference (WC) and waist hip ratio (WHR). Cut off values for BMI, WC and WHR were based on WHO criteria. Cut off values for FM% were based on earlier published recommendations. In addition we calculated FMI, and defined obesity as a FMI >90th percentile of the reference population.

    Classification of obesity BMI>30kg/m2 FMI > 90th percentile Fat percentage > 25% (men) or 35% (women) WC > 102cm (men) or 88cm (women) WHR > 0,90 (men) or 0,85 (women)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2014
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02320552
Sponsor's protocol ID
40480
Status last verified
Dec 2014
First submitted
10 Dec 2014
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Participant data will not be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Undernutrition and Renal Insufficiency, Chronic, run by Zealand University Hospital.

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 1 inclusion and 10 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Undernutrition (time frame: 3 months). 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 23 Sep 2026.

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