With this pilot study we want to see if there are measurable differences in body composition after one year. In what way does the body composition of patients change during the first year after transition from CHD to NHHD or NCHD? Is the weight gain…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Body weight (kg)
Fat mass (g)
Lean body mass (g) existing of muscles, bone tissue and fluids
Secondary outcome
hemoglobin (mmol/l), serum albumin (g/), serum calcium (mmol/l) and phosphate
(mmol/l)
equilibrated Kt/V (eKt/V) and Protein Catabolic Rate (PCR, g protein/ kg /day)
Background summary
Hemodialysis patients have a high risk of malnutrition. The cause of
malnutrition is multifactorial. Contributing factors are higher energy-needs,
chronic fatigue, the dialysis process itself, and reduced food intake. Reduced
food intake can have many causes like: less eating moments at dialysis days,
nausea as a result of hemodialysis, dietary restrictions, xerostomia, and
reduced taste perception.
Frequent nocturnal home hemodialysis (NHHD) is currently the most effective
method of hemodialysis and is associated with low blood levels of uremic
toxins. The patients dialyze 5 to 6 nights a week 8 hours during their sleep at
home. The conventional hemodialysis (CHD) scheme is 3 times a week 3 to 5 hours
dialysis. Patients on nocturnal in-centre hemodialysis (NCHD) dialyse on
alternate nights (every other night) 8 hours during their sleep in the dialysis
centre.
A research for changes in food intake at NHHD patients is currently going on in
Dialysis Centre Groningen (DCG). The first results show a weight gain and an
increase in energy intake after the transition from CHD to NHHD after 4 months,
after this first period it seems to stabilize. The same research is also
started in patients who started with NCHD. It is still unknown if the weight
gain is caused by an increase in fat, or an increase in lean body mass, or
maybe in both.
A literature study showed that Dual Energy X-ray Absorpiometry (DEXA) is the
best possible method to measure the body composition of dialysis patients.
Several studies published that DEXA is a safe, fast, and accurate measurement.
The measurement has a low burden for the patient, which makes this a suitable
measurement for dialysis patients.
Study objective
With this pilot study we want to see if there are measurable differences in
body composition after one year.
In what way does the body composition of patients change during the first year
after transition from CHD to NHHD or NCHD? Is the weight gain a result of an
increase in fat or in lean body mass? The body composition will be measured by
DEXA, Whole Body Composition (WBC).
Study design
A DEXA (WBC) scan will be done before the transition from CHD to NCHD/NHHD,
baseline, and after one year NCHD/NHHD the same measurement will be repeated.
Study burden and risks
The research is combined with a bone density measurement (bdm), which is a
standard measurement for these patients before start NHHD/NCHD and after 1
year. In total patients will have to spend 2 times 25 minutes with one year
interval.
Two times WBC and bdm DEXA will deliver a radiation burden of 0.316 mSv for the
research group. This is including the 0.30 mSv radiation burden of two times
the bdm.
For the control group the 2 WBC DEXA measurements will deliver a total
radiation burden of 0.016 mSv in one year.
Postbus 910
9700 AX Groningen
NL
Postbus 910
9700 AX Groningen
NL
Listed location countries
Age
Inclusion criteria
frequent home and in-centre nocturnal hemodialysis patients (age 18 years or older)
Exclusion criteria
short life expectance (<1 year), a substantial amount of metal in the body (artificial hip, pacemaker, and other), absence of informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19284.042.07 |