An interventional study of Trial 2 Exercise and Trial 1 Exercise in Metabolic Disease and Adipose Tissue, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by University of Michigan · Not applicable, Interventional, and Basic science
Among 272 studies in Metabolic Diseases with a site in United States — 68 open to participants now, 92 under way, 12 of them phase 3. Metabolic Diseases · United States.
Among the 272 studies in Metabolic Diseases with a site in United States, this one is the 143rd largest by enrollment of the 209 interventional ones that give a count, is one of 16 that started in 2016, is one of 88 with no phase, and was the 128th registered.
763 studies on the registry are indexed under Metabolic Diseases; 192 are open to participants now.
Browse Metabolic Diseases studies →68 of the 272 studies in Metabolic Diseases with a site in United States are open now. Recruiting first, the newest first:
Arrowhead Pharmaceuticals · Sites in United States, Denmark, Poland
University of Washington · Sites in United States, Netherlands
AstraZeneca · Sites in United States
Pfizer · Sites in United States, Brazil, Canada and 8 more countries
Miami University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 133 Metabolic Diseases studies recruiting now, 47 (35%) set no upper age limit and 63 (47%) stop at 75 or younger; 38 take children under 18; 50 take healthy volunteers.
This study: 18 Years to 40 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
272 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 39 · Phase 2 56 · Phase 3 42 · Phase 4 5
First in 1979; this study’s year is marked. 16 started in 2016.
This study's enrollment of 22 is below the median of 50 across 525 interventional studies indexed under Metabolic Diseases.
Median enrollment 50 across the 209 interventional studies, 100 across the 60 observational. Of the 162 that completed or were terminated, 83 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
114 of 272 have an industry lead sponsor. The 10 most frequent:
University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
University of Michigan has 6 studies filed under Metabolic Diseases — fewer than ten, so there is no comparison to draw.
26 of the studies in Metabolic Diseases with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT07723833AstraZenecaA Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants | 2026-11-18 |
| NCT06681428Tides MedicalRising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | 2026-11-18 |
| NCT06674980C5 BiomedicalClinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs | 2026-11-22 |
| NCT06689800Washington University School of MedicineLet's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy | 2026-11-30 |
Among the 272 studies in Metabolic Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
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).
Average Post-prandial glucose values
Average Post-prandial glucose values (1 hour, 2 hour, and 3 hours) will be measured
Time frame: 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
Time frame: 1 week
24 hour glycemic response
Average 24 hour glycemic response will be measured
Time frame: 1 day
Area under curve - 24 hour glycemic response
24 hour glycemic response area under curve will be measured
Time frame: 1 day
CGM Sensor Variability when measured simultaneously
coefficient variation of blood glucose between the 2 CGM devices placed during trial 1
Time frame: 1 week
Ran from Oct 2016 to primary completion in Dec 2017, 13 months.
Of 182 non-industry interventional studies with no phase under Metabolic Diseases, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 44. This study's 13 months is below that.
Counting every sponsor, half of 201 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.