Effects of Exercise and Energy Balance on 24-hour Blood Glucose Control
Condition: Metabolic Disease; Adipose Tissue
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The study team will assess "free-living" 24h glucose control using continuous glucose
      monitors (CGM) over an 88h period on two separate occasions. Importantly, standardized meals
      will be provided and will be consumed at specific times each day of the CGM measurement
      period. These meals will be identical on day 1 and day 3 of measurement. Each subject will
      complete two CGM periods, which will be identical except for the calorie and macronutrient
      content of the post-exercise dinner. In addition, during trial 1, two CGM's will be worn,
      while only 1 CGM will be worn on trial 2.
    

Detailed description: 
      Subjects will be instructed to exercise exactly 2 days before each experimental trial period,
      and then abstain from exercise other than the exercise session on Day 2 of the trial period
      until after the trial period is complete.

      Subjects will arrive to the Substrate Metabolism Laboratory at approximately 4pm on Day 0 of
      each trial. For trial 1, two CGM devices will be placed on either side of the abdomen, near
      the belly button. For trial 2, only one CGM device will be placed on one side of the abdomen.

      On Day 1 of both trials, participants will go about their normal daily activities (other than
      planned exercise) while eating provided meals at designated time points. This day will serve
      as the non-exercise control day.

      On Day 2, subjects will return to the laboratory to exercise on the bike for ~1h at a
      moderate exercise intensity (approximately 65% of their measured VO2peak) to expend 350
      kilocalories. During trial 1 only, subjects will use the mouthpiece and nose clip (which will
      allow all of their expired air to pass through the metabolic cart for analysis of oxygen
      consumption and carbon dioxide production) for ~5 min at the beginning, middle and toward the
      end of exercise to verify they are exercising at 65% of VO2peak. This will also allow the
      study team to accurately measure energy expenditure (kcal) during exercise. On trial 2,
      subjects will perform the exact same exercise protocol, but the mouthpiece and nose clip will
      not be required. One hour after the exercise session, participants will eat their
      standardized dinner. Importantly, the caloric content of this meal will differ between the
      two trials (+/- 350kcal), and this will be the only difference between the two study trial
      periods.

      On Day 3, participants will go about their normal daily activities (other than planned
      exercise) while eating the provided meals at designated time points. This day will serve as
      the post-exercise day.

      On Day 4, participants will return to the laboratory at approximately 8am for removal of the
      CGM device(s).
    

Intervention name(s): Trial 2 Exercise; Trial 1 Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): During the exercise session, subjects will exercise at 65% of VO2peak. One hour after the exercise session, participants will eat a standardized dinner which will NOT include the energy expended from their exercise session (- 350 kcal).; During the exercise session, subjects will use a mouthpiece and nose clip (which will allow all of their expired air to pass through the metabolic cart for analysis of oxygen consumption and carbon dioxide production) for ~5 min at the beginning, middle and toward the end of exercise to verify they are exercising at 65% of VO2peak. This will allow us to accurately measure energy expenditure (kcal) during exercise. One hour after the exercise session, participants will eat a standardized dinner which includes the energy expended from their exercise session (+ 350 kcal).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise