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Completed

NCT Number: NCT03350997

Effects of Exercise and Energy Balance on 24-hour Blood Glucose Control

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.

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Key information

Conditions

Metabolic Disease Adipose Tissue Behavior Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-40
  • Body Mass Index: 20-30 kg/m2

Exclusion criteria

  • Pregnant or lactating
  • Evidence/history of cardiovascular or metabolic disease
  • Medications known to affect glucose metabolism

Treatment and study plan

Trial 2 Exercise

Behavioral

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).

Trial 1 Exercise

Behavioral

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).

Primary outcomes

  1. Average Post-prandial glucose values

    Time frame: 1 week

    Average Post-prandial glucose values (1 hour, 2 hour, and 3 hours) will be measured

  2. area under curve Post-prandial glucose values (1 hour, 2 hour, and 3 hours)

    Time frame: 1 week

    1 hour, 2 hour, and 3 hours time-point for Post-prandial glucose values will be measured

Secondary outcomes

  1. 24 hour glycemic response

    Time frame: 1 day

    Average 24 hour glycemic response will be measured

  2. Area under curve - 24 hour glycemic response

    Time frame: 1 day

    24 hour glycemic response area under curve will be measured

  3. CGM Sensor Variability when measured simultaneously

    Time frame: 1 week

    coefficient variation of blood glucose between the 2 CGM devices placed during trial 1

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: CGM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2017
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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