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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03350997
Acronym
CGM
Enrollment
22
Registered
2017-11-22
Start date
2016-10-21
Completion date
2017-12-18
Last updated
2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adipose Tissue, Metabolic Disease

Keywords

Exercise

Brief 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).

Interventions

BEHAVIORALTrial 2 Exercise

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).

BEHAVIORALTrial 1 Exercise

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).

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Average Post-prandial glucose values1 weekAverage Post-prandial glucose values (1 hour, 2 hour, and 3 hours) will be measured
area under curve Post-prandial glucose values (1 hour, 2 hour, and 3 hours)1 week1 hour, 2 hour, and 3 hours time-point for Post-prandial glucose values will be measured

Secondary

MeasureTime frameDescription
24 hour glycemic response1 dayAverage 24 hour glycemic response will be measured
Area under curve - 24 hour glycemic response1 day24 hour glycemic response area under curve will be measured
CGM Sensor Variability when measured simultaneously1 weekcoefficient variation of blood glucose between the 2 CGM devices placed during trial 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026