Study of Gluconeogenesis in Very Low Birth Weight Infants Receiving Total Parenteral Nutrition
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Very low birth weight infants have problems maintaining normal blood sugar levels. Gluconeogenesis is the production of sugar from amino acids and fats. The best combination of amino acids, fat, and sugar to help very low birth weigh infants maintain normal blood sugar levels is not yet known.
PURPOSE: Clinical trial to study how very low birth weight infants break down amino acids, fat, and sugar given by intravenous infusion, and the effect of different combinations of nutrients on the infants' ability to maintain normal blood sugar levels.
详细描述
PROTOCOL OUTLINE: Patients are assigned to one of 6 study groups.
Patients receive infusions of stable isotope tracers: [15N]urea IV beginning at -12 hours and continuing over 22 hours to measure protein oxidation; [U-13C]glucose IV beginning at zero hour and continuing over 10 hours to measure glucose appearance rate and gluconeogenesis; [2-13C]glycerol IV over 10 hours to measure lipolysis; and [1-C]leucine IV over 10 hours to measure proteolysis. Blood samples are obtained before the start of the urea tracer infusion; before the start of the glucose, glycerol, and leucine tracer infusions; and at study hours 4, 4.5, 5, 9, 9.5, and 10. Blood glucose is measured hourly, and patients receive glucose IV if blood glucose falls below 40 mg/dL.
Group I: Patients are randomized to one of two study arms. Arm I: Patients receive standard total parenteral nutrition (TPN), except the [U-13C]glucose is substituted for a portion of the glucose. Arm II: The infusions of lipids (Intralipid) and amino acids (TrophAmine) are discontinued at study hour zero. The infusion rate of natural glucose will be reduced during the first hour, and thereafter discontinued.
Group II: Patients are randomized to receive either TrophAmine or Intralipid IV over the last 5 hours of the study.
Group III: Patients are randomized to receive one of two different doses of glycerol IV over the last 5 hours of the study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 4 Days 至 6 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable, very low birth weight infants (750-1,500 grams)
- •Normal blood glucose values OR Blood glucose greater than 175 mg/dL
- •No prior insulin
- •No sepsis Oxygen supply less than 30% Normal acid base status
- •No malformation
- •No discernible diseases
排除标准
- 未提供