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

• ClinicalTrials.gov Identifier: NCT03350997
• Recruitment Status: Active, not recruiting
• First Posted: November 22, 2017
• Last Update Posted: January 21, 2019
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Jeffrey F Horowitz, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Disease; Adipose Tissue	Behavioral: Trial 2 Exercise; Behavioral: Trial 1 Exercise	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effects of Exercise and Energy Balance on 24-hour Blood Glucose Control
• Actual Study Start Date: October 21, 2016
• Estimated Primary Completion Date: November 2022
• Estimated Study Completion Date: November 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Trial 1; Subjects will have two CGM devices placed on either side of the abdomen, near the belly button. Trial 1 Exercise - 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).	Behavioral: Trial 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).
Experimental: Trial 2; Subjects will have one CGM device placed on one side of the abdomen. Trial 2 Exercise - 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).	Behavioral: Trial 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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: Jeffrey F Horowitz; University of Michigan

More Information

• Responsible Party: Jeffrey F Horowitz, Associate Professor, Movement Science, School of Kinesiology, University of Michigan
• ClinicalTrials.gov Identifier: NCT03350997 History of Changes
• Other Study ID Numbers: HUM00120520
• First Posted: November 22, 2017
• Last Update Posted: January 21, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeffrey F Horowitz, University of Michigan:

Exercise

Additional relevant MeSH terms:

Metabolic Diseases