Metabolic DiseaseCGMNCT03350997
Effects of Exercise and Energy Balance on 24-hour Blood Glucose Control
A study testing Trial 2 Exercise and Trial 1 Exercise in people with Metabolic Disease and Adipose Tissue, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Adipose Tissue
- What is being tested?
- Trial 2 Exercise and Trial 1 Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2016to 18 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-40
- Body Mass Index: 20-30 kg/m2
Who cannot join
- Pregnant or lactating
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Metabolic Disease, Adipose Tissue
- Being tested
- Trial 2 Exercise, Trial 1 Exercise
- Keywords
- Exercise
- Medical subject headings
- Metabolic Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trial 2 ExerciseBehavioural
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 ExerciseBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Trial 1 | Experimental | 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). Receives: Behavioral: Trial 1 Exercise |
| Trial 2 | Experimental | 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). Receives: Behavioral: Trial 2 Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Post-prandial glucose values
Average Post-prandial glucose values (1 hour, 2 hour, and 3 hours) will be measured
Measured: 1 week
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
Measured: 1 week
Secondary outcomes (3)
24 hour glycemic response
Average 24 hour glycemic response will be measured
Measured: 1 day
Area under curve - 24 hour glycemic response
24 hour glycemic response area under curve will be measured
Measured: 1 day
CGM Sensor Variability when measured simultaneously
coefficient variation of blood glucose between the 2 CGM devices placed during trial 1
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start21 Oct 2016
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey F Horowitz, University of Michigan
- Investigators
- Jeffrey F Horowitz, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350997
- Sponsor's protocol ID
- HUM00120520
- Acronym
- CGM
- Status last verified
- Mar 2022
- First submitted
- 13 Nov 2017
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Energy Balance on 24-hour Blood Glucose Control
- ClinicalTrials.gov ID
- NCT03350997
- Acronym / sponsor ID
- CGM / HUM00120520
- Conditions
- Metabolic Disease, Adipose Tissue
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial 1 | Experimental | Behavioral: Trial 1 ExerciseSubjects 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). |
| Trial 2 | Experimental | Behavioral: Trial 2 ExerciseSubjects 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 18-40
- Body Mass Index: 20-30 kg/m2
Key exclusion criteria (3 listed)
- Pregnant or lactating
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect glucose metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trial 2 ExerciseDuring 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). | Behavioural | Trial 2 |
| Trial 1 ExerciseDuring 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). | Behavioural | Trial 1 |
Primary outcome
Average Post-prandial glucose values
Time frame: 1 week
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)
Time frame: 1 week
1 hour, 2 hour, and 3 hours time-point for Post-prandial glucose values will be measured
3 secondary outcomes
24 hour glycemic response
Time frame: 1 day
Area under curve - 24 hour glycemic response
Time frame: 1 day
CGM Sensor Variability when measured simultaneously
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey F Horowitz principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trial 2 Exercise and Trial 1 Exercise in people with Metabolic Disease and Adipose Tissue, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Post-prandial glucose values (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.