This study aims to determine the effect of nocturnal versus daytime cyclic infusion of parenteral nutrition in adult chronic intestinal failure patients on bone turnover, glucose metabolism, nitrogen balance, sleep and wake rhythm and clock genes…
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Bone, calcium, magnesium and phosphorus metabolism disorders
Synonym
Health condition
sleep - wake rhythm, nitrogen balance and clock gene expression
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in the bone turnover markers serum P1NP and CTX-1, changes in
glucose variability measured by a continuous glucose monitor and changes in
insulin levels.
Secondary outcome
Differences in nitrogen balance, sleep/wake rhythm, clock gene expression,
resting energy expenditure and substrate oxidation rates, body temperature
Background summary
Many chronic intestinal failure patients are on cyclic infusion of parenteral
nutrition during the nighttime for practical reasons, but this pattern of
feeding is not concordant with their biological clock. Nocturnal parenteral
nutrition may negatively affect bone turnover, nitrogen balance, sleep/wake
rhythms and glucose metabolism. Diurnal administration of parenteral nutrition
is expected to be more in line with the biological clock and can possibly lead
to fewer complications due to circadian desynchronization.
Study objective
This study aims to determine the effect of nocturnal versus daytime cyclic
infusion of parenteral nutrition in adult chronic intestinal failure patients
on bone turnover, glucose metabolism, nitrogen balance, sleep and wake rhythm
and clock genes expression.
Study design
We will conduct a randomized crossover pilot study
Intervention
patients will receive nocturnal parenteral nutrition for 1 week (period A) and
will switch to diurnal parenteral nutrition (period B) for 1 week. At the start
of the study, patients will be randomly assigned to study period A or B and
will cross over after the first study period. After both study periods,
patients will be admitted to the metabolic unit for 24 hours to measure bone
turnover markers, nitrogen balance, glucose variability, glucoregulatory
hormones, energy expenditure and substrate oxidation rates and clock gene
expression in leukocytes.
Study burden and risks
patients will wear an actigraph and a continuous glucose monitor for 14 days (2
study periods). They will report their sleep quality and oral intake during
both study periods. Patients will be admitted to the metabolic unit twice for
24-hous. They will undergo blood sampling 6 times, (resting) energy expenditure
and substrate oxidation rates measurements 6 times and will wear multiple
i-buttons for measuring body temperature. They are asked to sample their urine
and faeces output for 24-hours.
All risks related to the presence of the central venous catheter and the use of
parenteral nutrition are pre-existing risks associated with the underlying
disease. We do ask patients to switch temporally to diurnal parenteral
nutrition, which can have impact on their daily routine for a maximum of 1
week. Placing a cannula for blood sampling can be an unpleasant experience for
the patients. There is a low risk of phlebitis; this is unpleasant, but not
harmful, of temporary nature and self-limiting.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Chronic intestinal failure
Parenteral nutrition for at least 3 nights a week
Parenteral nutrition for more than 1 year
No major changes in parenteral nutrition for 3 months prior to inclusion
Exclusion criteria
Parenteral infusion for more than 16 h a day
Use of bone modifying drugs in the last 2 years
Bone fractures in the past year
Renal insufficiency (eGFR < 30 ml/min)
HbA1c >=53 mmol/ml
Use of corticosteroids (systemic, cutaneous >5cm2 or WHO class I-III)
Shift work
Performing intensive exercise (> 2 hours a day and > 3 times a week)
Design
Recruitment
Medical products/devices used
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 | NL82280.018.22 |