1. To assess whether the skeletal muscle protein fractional synthesis rate as measured by the deuterated water method is different during a 1-week habitual lifestyle period when compared to a 1-week period with resistance-type exercise and protein…
ID
Source
Brief title
Condition
- Other condition
- Nephropathies
Synonym
Health condition
Skeletspier aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes in this study will be daily muscle protein synthesis rates
as measured by the deuterated water method.
Secondary outcome
Secondary study parameters include muscle mitochondrial bioenergetics, muscle
fiber size, leg lean mass, and aerobic capacity muscle mitochondrial
bioenergetics, saliva 2H enrichment, food intake, and physical activity
levels.at baseline.
Background summary
When patients progress to the final stage of chronic kidney disease (CKD) and
require hemodialysis treatment, they typically have lost so much muscle
function that they are no longer physically independent. However, due to
disease- and hemodialysis-related muscle catabolism, dietary protein and
exercise interventions are only capable to attenuate the decline in physical
function of patients on hemodialysis treatment. Therefore, lifestyle
interventions to increase muscle function should be implemented before
hemodialysis is required. However, it is still a matter of debate whether
muscle protein synthesis rates of patients with advanced CKD can be increased
with a patient-tailored dietary protein and exercise intervention.
Study objective
1. To assess whether the skeletal muscle protein fractional synthesis rate as
measured by the deuterated water method is different during a 1-week habitual
lifestyle period when compared to a 1-week period with resistance-type exercise
and protein supplementation in patients with advanced CKD.
2. To assess whether the skeletal muscle protein fractional synthesis rate as
measured by the deuterated water method differs between patients with advanced
CKD and healthy adult controls without CKD, and whether this is affected by a
1-week habitual lifestyle period versus a 1-week period with resistance-type
exercise and protein supplementation.
Study design
Randomized cross-over (two treatments) design.
Intervention
Participants will, in a randomized order, be assigned to 1 week of
resistance-type exercise training and protein supplementation and 1 week of
continuing their habitual lifestyle.
Study burden and risks
The burden and risks involved in participating in this experiment are small.
Deuterated water (isotopically labelled water, 2H2O, or *heavy water*)
ingestion has been previously used in numerous published studies and is
entirely safe and non-toxic when body water enrichments are below approximately
20 mol%. For the current study, body water enrichment will be approximately 1-2
mol%. Muscle biopsies will be obtained under local anesthesia by an experienced
physician but may cause some minor discomfort. The discomfort is comparable to
muscle soreness or pain comparable to bumping into the corner of a table.
During the experimental trial 5 blood samples (100 mL in total) will be
obtained through a venipuncture, with the risk of a small local hematoma.
Though patients do not directly benefit from participation in the current
study, it will provide knowledge about the impact of exercise training and
physical activity in patients with CKD, which may help to improve clinical
outcomes.
Universiteitsingel 50
Maastricht 6229 ER
NL
Universiteitsingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
1. In order to be eligible to participate in this study, a patient with CKD
must meet all of the following criteria:
• (e)glomerular filtration rate (GFR) <45 ml/min/1.73m2
• Age: 18 - 80 y
• Able to provide written informed consent
2. In order to be eligible to participate in this study, a healthy subject must
meet all of the following criteria:
• (e)GFR >60 ml/min//1.73m2 without albuminuria
• Age: 18 - 80 y
• Able to provide written informed consent
Exclusion criteria
• Insulin-dependent diabetes mellitus or two or more oral glucose lowering
medications
• Active inflammatory disease / malignancies
• Uncontrolled hypertension (>160/100mm Hg), unstable angina pectoris, or
arrhythmia
• Pulmonary disease restricting exercise performance (e.g. COPD)
• A history of neuromuscular problems
• Cognitive Impairment
• Diagnosed GI tract diseases / dysphagia
• Allergies to milk proteins / Lactose intolerance
• Pregnancy
• Hospitalization <1 months prior to study period
• Participation in any structured exercise program
• Any medications known to affect protein metabolism (i.e. corticosteroids or
prescription strength acne medications).
• Use of DOAC, vitamin-K-antagonist, or multiple anticoagulants.
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 |
|---|---|
| Other | Clinicaltrials.gov nummer volgt |
| CCMO | NL81442.068.22 |