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临床试验/NCT06115616
NCT06115616已完成不适用

The Impact of Morning Versus Afternoon Aerobic Exercise on Carbohydrate and Lipid Metabolism in Type 1 Diabetes

University of Aarhus1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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