The Impact of Morning Versus Afternoon Aerobic Exercise on Carbohydrate and Lipid Metabolism in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- g of glucose
研究概览
简要总结
Aim. To determine whether the need for exogenous carbohydrate supplementation during exercise in type 1 diabetes is lower during morning exercise compared to afternoon exercise, and whether this is associated with greater lipid oxidation in the morning.
Design and methods Twelve subjects with type 1 diabetes will participate in a randomized crossover study. Subjects will perform moderate intensity at 60% of VO2max for 1 hour during one morning (9 AM) and one afternoon (4 PM). Glucose monitoring will occur every 10 minutes during exercise, and every 5 minutes if blood glucose drops below 3.9 mmol/l. If blood glucose drops below 3.9 mmol/l, glucose infusion will be administered at a rate that keeps blood glucose just above 5 mmol/l. Glucose and palmitate tracers will be infused and indirect calorimetry will be used to assess glucose and lipid metabolism. Blood samples will be gathered to measure tracer levels, growth hormone, cortisol, and free fatty acids (FFA).
Endpoints: Volume of intravenous glucose needed to maintain glucose above 5 mmol/l during the two exercise bouts, lipid- and carbohydrate oxidation rates, time to hypoglycemia, delta blood glucose levels, lipolysis rate, and endogenous glucose production.
详细描述
Aim. To determine whether the need for exogenous carbohydrate supplementation during exercise in type 1 diabetes is lower during morning exercise compared to afternoon exercise, and whether this is associated with greater lipid oxidation in the morning.
Rationale. Carbohydrate intake requirements to prevent hypoglycemia may vary throughout the day. Determining whether increased carbohydrate requirements are needed in the afternoon will help patients avoid hypoglycemia.
Design and methods Twelve subjects with type 1 diabetes [age 18-65, male/female, >2 years of diabetes duration, multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII))] will participate in a randomized crossover study. Subjects will perform moderate intensity at 60% of VO2max for 1 hour during one morning (9 AM) and one afternoon (4 PM). For both morning and afternoon exercise bouts, subjects will be asked to refrain from exercise for 48hours prior to the test. For the morning exercise bout, the night before subjects will consume a standardized meal at 7 pm, followed by an overnight fast. The afternoon exercise test will be performed 5 hours after an early standardized lunch with full dose of rapid-acting insulin. Basal insulin will be continued in the usual dosage, and starting blood glucose value will be standardized to target 7.0 mmol/l with acceptable range 5.0-9.0 mmol/l prior to initiation of the exercise session. Glucose monitoring will occur every 10 minutes during exercise, and every 5 minutes if blood glucose drops below 3.9 mmol/l. If blood glucose drops below 3.9 mmol/l, an unlabeled glucose infusion will be administered at a rate that keeps blood glucose just above 5 mmol/l.
Glucose and palmitate tracers will be infused to determine differences in diurnal glucose and lipid metabolism during exercise. Indirect calorimetry will be used to measure glucose and lipid oxidation rates. Blood samples will be gathered to measure tracer levels, growth hormone, cortisol, and free fatty acids (FFA) pre-exercise, during exercise, and post-exercise. Continuous glucose monitoring (CGM) and accelerometer activity and sleep data will be collected 24 hours before exercise and for 24 hours after the exercise bout.
Endpoints. The primary endpoint will be the volume of intravenous glucose (g of glucose) needed to maintain glucose above 5 mmol/l during the two exercise bouts. The secondary endpoints will be Lipid- and carbohydrate oxidation rates, time to hypoglycemia, delta blood glucose levels, lipolysis rate, and endogenous glucose production.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65
- •male/female
- •>2 years of type 1diabetes duration
- •multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
- •physically active
排除标准
- •heart conditions
- •unawareness
- •severe complications to diabetes
研究组 & 干预措施
Exercise
干预措施: Morning exercise (Behavioral)
Exercise
干预措施: Afternoon exercise (Behavioral)
结局指标
主要结局
g of glucose
时间窗: 4 hours
The primary endpoint will be the volume of intravenous glucose (g of glucose) needed to maintain glucose above 5 mmol/l during the two exercise bouts. During the study day, blood glucose is monitored 2 hours prior to the exercise bout, during the 1 hour exercise bout and 1 hour after the exercise bout. If blood glucose drops below 3.9 mmol/l, glucose infusion is initiated to keep blood glucose just above 5 mmol/l and volume of iv glucose (translated to g of glucose) is recorded. This is done during the 2 study days, and these study days are held 1-3 weeks apart.
次要结局
未报告次要终点
