search
Back to results

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

Primary Purpose

Metabolic Disease, Adipose Tissue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trial 2 Exercise
Trial 1 Exercise
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Disease focused on measuring Exercise

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Trial 1

Trial 2

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

24 hour glycemic response
Average 24 hour glycemic response will be measured
Area under curve - 24 hour glycemic response
24 hour glycemic response area under curve will be measured
CGM Sensor Variability when measured simultaneously
coefficient variation of blood glucose between the 2 CGM devices placed during trial 1

Full Information

First Posted
November 13, 2017
Last Updated
March 18, 2022
Sponsor
University of Michigan
search

1. Study Identification

Unique Protocol Identification Number
NCT03350997
Brief Title
Effects of Exercise and Energy Balance on 24-hour Blood Glucose Control
Acronym
CGM
Official Title
Effects of Exercise and Energy Balance on 24-hour Blood Glucose Control
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 21, 2016 (Actual)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
December 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease, Adipose Tissue
Keywords
Exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Trial 2
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Trial 2 Exercise
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Trial 1 Exercise
Intervention Description
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 Outcome Measure Information:
Title
Average Post-prandial glucose values
Description
Average Post-prandial glucose values (1 hour, 2 hour, and 3 hours) will be measured
Time Frame
1 week
Title
area under curve Post-prandial glucose values (1 hour, 2 hour, and 3 hours)
Description
1 hour, 2 hour, and 3 hours time-point for Post-prandial glucose values will be measured
Time Frame
1 week
Secondary Outcome Measure Information:
Title
24 hour glycemic response
Description
Average 24 hour glycemic response will be measured
Time Frame
1 day
Title
Area under curve - 24 hour glycemic response
Description
24 hour glycemic response area under curve will be measured
Time Frame
1 day
Title
CGM Sensor Variability when measured simultaneously
Description
coefficient variation of blood glucose between the 2 CGM devices placed during trial 1
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey F Horowitz
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs