The Effect of Parenteral Nutrition During Nighttime Versus Daytime on Bone Turnover and Energy Metabolism in Intestinal Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in glucose variability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Nocturnal parenteral nutrition
Patients will receive nocturnal parenteral nutrition, starting at 8pm
干预措施: Parenteral nutrition (Dietary Supplement)
Diurnal parenteral nutrition
Patients will receive diurnal parenteral nutrition, starting at 8am
干预措施: Parenteral nutrition (Dietary Supplement)
结局指标
主要结局
Changes in glucose variability
时间窗: 2 weeks versus 2 weeks
Changes in glucose variability measured by a continuous glucose monitor
Differences in bone turnover marker Procollagen 1 Intact N-Terminal Propeptide
时间窗: 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
时间窗: Study day 1 versus study day 2
Differences in bone turnover marker carboxy-terminal collagen crosslinks (ng/L)
次要结局
- Changes in sleep/wake rhythm(2 weeks versus 2 weeks)
- Changes in plasma insulin(Study day 1 versus study day 2)
- Changes in plasma glucagon(Study day 1 versus study day 2)
- Changes in nitrogen balance(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)
研究者
Prof. Dr. Mireille JM Serlie
prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)