An interventional study of Parenteral nutrition and Parenteral nutrition in Intestinal Failure, Osteoporosis and Insulin Sensitivity, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Other
This clinical trial will study the effect of daytime versus nighttime parenteral nutrition on bone turnover, glucose variability, nitrogen balance, sleep and wake rhythm and peripheral clock gene expression in patients with chronic intestinal failure.
Objective: This randomized crossover pilot study aims to determine the effect of nocturnal versus daytime cyclic infusion of parenteral nutrition in adult patients with chronic intestinal failure on bone turnover, glucose metabolism, nitrogen balance, sleep and wake rhythm and clock genes expression.
This study will include 20 adult patients with chronic intestinal failure. Patients will receive nocturnal parenteral nutrition for 2 weeks (period A) and will switch to daytime parenteral nutrition (period B) for 2 weeks (random assignment). During both study periods glucose variability and sleep / wake rhythm will be measured. After both study periods, patients will be admitted to the metabolic unit for 24 hours to measure bone turnover markers, nitrogen balance, glucoregulatory hormones, energy expenditure and substrate oxidation rates and clock gene expression in leukocytes.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's planned enrollment of 20 is below the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive nocturnal parenteral nutrition, starting at 8pm
Dietary Supplement: Parenteral nutrition
Patients will receive diurnal parenteral nutrition, starting at 8am
Dietary Supplement: Parenteral nutrition
Parenteral nutrition will be administered starting at 8 pm
Also known as: active comparator
Parenteral nutrition will be administered starting at 8 am
Also known as: experimental
Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide
Differences in the bone turnover marker Procollagen 1 Intact N-Terminal Propeptide (ug/L)
Time frame: Study day 1 versus study day 2
Differences in bone turnover marker carboxy-terminal collagen crosslinks
Differences in bone turnover marker carboxy-terminal collagen crosslinks (ng/L)
Time frame: Study day 1 versus study day 2
Changes in glucose variability
Changes in glucose variability measured by a continuous glucose monitor
Time frame: 2 weeks versus 2 weeks
Changes in plasma insulin
insulin (pmol/L)
Time frame: Study day 1 versus study day 2
Changes in plasma glucagon
glucagon (ng/L)
Time frame: Study day 1 versus study day 2
Changes in nitrogen balance
Changes in nitrogen balance by comparing output (feces/urine) versus intake (oral/enteral/parenteral)
Time frame: Study day 1 versus study day 2
Changes in sleep/wake rhythm
Changes in sleep/wake rhythm measured by an actigraph
Time frame: 2 weeks versus 2 weeks
Changes in sleep quality
Changes in sleep quality, measured by Visual Analogue Scale (VAS) score (scale 1-10, higher scores mean better outcome)
Time frame: 2 weeks versus 2 weeks
Changes in clock gene expression
Changes in clock gene expression in leukocytes (if feasible; pilot)
Time frame: Study day 1 versus study day 2
Changes in energy expenditure
Changes in energy expenditure assessed by indirect calorimetry (kcal/24h)
Time frame: Study day 1 versus study day 2
Changes in substrate oxidation rates
Changes in substrate oxidation rates assessed by indirect calorimetry (percent)
Time frame: Study day 1 versus study day 2
Changes in body temperature
Changes in body temperature measured by i-buttons (Celsius)
Time frame: Study day 1 versus study day 2
Plan to share: Yes — Non-identifiable data will be available after signing a data sharing agreement with the legal support office of the Amsterdam University Medical Center
Supporting information: Study protocol, Statistical analysis plan
Time frame: After publication of the study results and for a period of 15 years
Access criteria: Data sharing agreement with legal support office
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