- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03350997
Effects of Exercise and Energy Balance on 24-hour Blood Glucose Control (CGM)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Post-prandial glucose values
Time Frame: 1 week
|
Average Post-prandial glucose values (1 hour, 2 hour, and 3 hours) will be measured
|
1 week
|
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
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24 hour glycemic response
Time Frame: 1 day
|
Average 24 hour glycemic response will be measured
|
1 day
|
Area under curve - 24 hour glycemic response
Time Frame: 1 day
|
24 hour glycemic response area under curve will be measured
|
1 day
|
CGM Sensor Variability when measured simultaneously
Time Frame: 1 week
|
coefficient variation of blood glucose between the 2 CGM devices placed during trial 1
|
1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00120520
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metabolic Disease
-
Yonsei UniversityUnknownCardiovascular Disease | Metabolic DiseaseKorea, Republic of
-
Clinical Nutrition Research Centre, SingaporeCompletedCardiovascular Disease | Metabolic Disease
-
San Diego State UniversityRecruitingBone Disease, MetabolicUnited States
-
Hospital Clinic of BarcelonaNovartisCompletedBone Disease, MetabolicSpain
-
The Hospital for Sick ChildrenRare Disease Foundation, Vancouver, CanadaCompleted
-
Istituto Ortopedico RizzoliCompletedOsteopenia | Bone Disease, MetabolicItaly
-
Shenzhen Center for Chronic Disease ControlCompletedNutrition Disorders | Genetic Predisposition to Disease | Metabolic DiseaseChina
-
National Institutes of Health Clinical Center (CC)CompletedVascular Diseases | Cancer | Metabolic Bone Disease | Inflammatory DiseaseUnited States
-
Istituto Ortopedico GaleazziUnknownPhysical Activity | Bone Disease, MetabolicItaly
-
Stanley Dudrick's Memorial HospitalCompletedMetabolic Bone DiseasePoland
Clinical Trials on Trial 1 Exercise
-
Democritus University of ThraceCompleted
-
Kristin Zhao, PhDSoutheastern Minnesota Center for Independent LivingTerminatedPhysical Disability | Neurologic DysfunctionUnited States
-
University of BathUniversity of Southampton; Royal United Hospitals Bath NHS Foundation Trust; Great...CompletedChronic Lymphocytic Leukemia | Minimal Residual DiseaseUnited Kingdom
-
University of British ColumbiaCompleted
-
Novo Nordisk A/SCompleted
-
National Taiwan University HospitalRecruitingVentilator WeaningTaiwan
-
The University of Texas Health Science Center,...Children's Hospital of Philadelphia; National Institute of Diabetes and Digestive...CompletedHypertension | Chronic Kidney DiseasesUnited States
-
Virginia Commonwealth UniversityGilead SciencesWithdrawnChronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | CLL | Refractory Small Lymphocytic Lymphoma | SLL | Relapsed CLL | Relapsed Chronic Lymphocytic Leukemia | Relapsed Small Lymphocytic Lymphoma
-
University of Wisconsin, MadisonNational Heart, Lung, and Blood Institute (NHLBI)Terminated
-
University Health Network, TorontoCompletedProstate CancerCanada