Effect of Nocturnal Parenteral Nutrition on Bone Turnover and Energy Metabolism
- Conditions
- Intestinal FailureOsteoporosisInsulin Sensitivity
- Interventions
- Dietary Supplement: Parenteral nutrition
- Registration Number
- NCT05868785
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Home parenteral nutrition for at least 5 nights a week
- On home parenteral nutrition for more than 1 year
- No major changes in parenteral nutrition for 3 months prior to inclusion
- 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 < 60 ml/min)
- HbA1c ≥48 mmol/ml
- Use of corticosteroids
- Shift work
- Performing intensive exercise (> 2 hours a day and > 3 times a week)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Diurnal parenteral nutrition Parenteral nutrition Patients will receive diurnal parenteral nutrition, starting at 8am Nocturnal parenteral nutrition Parenteral nutrition Patients will receive nocturnal parenteral nutrition, starting at 8pm
- Primary Outcome Measures
Name Time Method Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide Study day 1 versus study day 2 Differences in the bone turnover marker Procollagen 1 Intact N-Terminal Propeptide (ug/L)
Differences in bone turnover marker carboxy-terminal collagen crosslinks Study day 1 versus study day 2 Differences in bone turnover marker carboxy-terminal collagen crosslinks (ng/L)
Changes in glucose variability 2 weeks versus 2 weeks Changes in glucose variability measured by a continuous glucose monitor
- Secondary Outcome Measures
Name Time Method Changes in plasma insulin Study day 1 versus study day 2 insulin (pmol/L)
Changes in plasma glucagon Study day 1 versus study day 2 glucagon (ng/L)
Changes in nitrogen balance Study day 1 versus study day 2 Changes in nitrogen balance by comparing output (feces/urine) versus intake (oral/enteral/parenteral)
Changes in sleep quality 2 weeks versus 2 weeks Changes in sleep quality, measured by Visual Analogue Scale (VAS) score (scale 1-10, higher scores mean better outcome)
Changes in clock gene expression Study day 1 versus study day 2 Changes in clock gene expression in leukocytes (if feasible; pilot)
Changes in energy expenditure Study day 1 versus study day 2 Changes in energy expenditure assessed by indirect calorimetry (kcal/24h)
Changes in substrate oxidation rates Study day 1 versus study day 2 Changes in substrate oxidation rates assessed by indirect calorimetry (percent)
Changes in sleep/wake rhythm 2 weeks versus 2 weeks Changes in sleep/wake rhythm measured by an actigraph
Trial Locations
- Locations (1)
Amsterdam University Medical Center
🇳🇱Amsterdam, North Holland, Netherlands