Morning Versus Afternoon Aerobic Exercise in Type 1 Diabetes

NCT06115616 | Unknown DMC

• 1 other identifier: 97516
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

• g of glucose

  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.

  4 hours

Study Arms (1)

Exercise

Behavioral: Morning exercise; Behavioral: Afternoon exercise

Interventions

Morning exercise BEHAVIORAL

Exercise before noon in the morning

Exercise

Afternoon exercise BEHAVIORAL

Exercise in the late after noon

Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* age 18-65 * male/female * \>2 years of type 1 diabetes duration * multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) * physically active

You may qualify if:

• age 18-65
• male/female
• \>2 years of type 1diabetes duration
• multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
• physically active

You may not qualify if:

• heart conditions
• unawareness
• severe complications to diabetes

Sponsors & Collaborators

• University of Aarhus: lead

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 3, 2023
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 3, 2023

Record last verified: 2023-10