Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT06115616
Status:
UNKNOWN
Last Update Posted:
2023-11-03
First Post:
2023-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Morning Versus Afternoon Aerobic Exercise in Type 1 Diabetes
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
The Impact of Morning Versus Afternoon Aerobic Exercise on Carbohydrate and Lipid Metabolism in Type 1 Diabetes
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
Sample size. A sample size of 12 subjects was chosen by use of power calculations based on alike previous studies, and based on clinical observations of carbohydrate requirements during morning and afternoon exercise (expected difference in carbohydrate supplementation of 20 g with a standard deviation of 15 g).
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.
Sample size. A sample size of 12 subjects was chosen by use of power calculations based on alike previous studies, and based on clinical observations of carbohydrate requirements during morning and afternoon exercise (expected difference in carbohydrate supplementation of 20 g with a standard deviation of 15 g).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: