The Effect of Parenteral Nutrition During Nighttime Versus Daytime on Bone Turnover and Energy Metabolism in Intestinal Failure Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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 < 60 ml/min)
- •HbA1c ≥48 mmol/ml
- •Use of corticosteroids
- •Shift work
- •Performing intensive exercise (> 2 hours a day and > 3 times a week)
Outcomes
Primary Outcomes
Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide
Time Frame: 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
Time Frame: Study day 1 versus study day 2
Differences in bone turnover marker carboxy-terminal collagen crosslinks (ng/L)
Changes in glucose variability
Time Frame: 2 weeks versus 2 weeks
Changes in glucose variability measured by a continuous glucose monitor
Secondary Outcomes
- Changes in nitrogen balance(Study day 1 versus study day 2)
- Changes in plasma glucagon(Study day 1 versus study day 2)
- Changes in plasma insulin(Study day 1 versus study day 2)
- Changes in sleep quality(2 weeks versus 2 weeks)
- Changes in clock gene expression(Study day 1 versus study day 2)
- Changes in energy expenditure(Study day 1 versus study day 2)
- Changes in substrate oxidation rates(Study day 1 versus study day 2)
- Changes in sleep/wake rhythm(2 weeks versus 2 weeks)
Investigators
Prof. Dr. Mireille JM Serlie
prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)