ObesityWAXNCT05806801
Metabolic Adaptations to Weight Loss With and Without Exercise
A study testing MICT Exercise in people with Obesity and Metabolic Disease, run by University of Michigan at 1 site in United States.
Trial summary
Study Purpose: The combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Disease, Metabolic Syndrome
- What is being tested?
- MICT Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2023to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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: 30-40 kg/m2
- Weight stable (±3kg for greater than or equal to about 2 months)
- No regularly planned exercise/physical activity
- Women must have regularly occurring menses and must be premenopausal
Who cannot join
- EKG abnormalities
- Evidence/history of cardiovascular disease, diabetes or other metabolic disease
- Medications known to affect lipid or glucose metabolism
- Pregnant or lactating
- Tobacco or e-cigarette use
- Prior experience of hypersensitivity to insulin, human albumin, and potassium chloride injection.
Show all 9Show fewer
- Allergies/hypersensitivity to local anesthetics of the amide type (e.g., lidocaine)
- History of hyperkalemia or potential for developing hyperkalemia (including but not limited to taking drugs that may induce hyperkalemia such as cardiac glycosides or potassium sparing diuretics)
- Anti-coagulant medication (e.g., Coumadin, Rivaroxaban) and Lidocaine allergy/sensitivity are exclusion criteria for the biopsy procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Suzette Howton, 7346479850, suzetter@med.umich.edu
Jeff F Horowitz, PhD
About this study
Study Purpose:
The combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. A deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment/prevention of obesity-related diseases.
Read more
Although a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. This is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. We argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained
Study Summary:
10% Weight Loss Phase - Subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). During this, subjects will be randomized into one of two different experimental groups:
- Moderate Intensity Continuous Training (MICT) exercise group
- No exercise (control) group
Follow-up Phase: After completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise/physical activity behavior. Subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss.
Total involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).
- Conditions
- Obesity, Metabolic Disease, Metabolic Syndrome, Insulin Sensitivity, Insulin Resistance, Weight Loss
- Being tested
- MICT Exercise, No Exercise (Control)
- Medical subject headings
- Obesity, Metabolic Diseases, Metabolic Syndrome, Insulin Resistance, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICT ExerciseBehavioural
Subjects randomized into this group will complete a moderate intensity continuous exercise 4 days/week.
No Exercise (Control)Behavioural
Subjects randomized into this group will remain sedentary throughout the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Continuous Training (MICT) exercise group | Experimental | 45 minutes of continuous steady-state exercise at 70% maximal heart rate throughout the 10% weight loss phase of the study Receives: Behavioral: MICT Exercise |
| No exercise (Control) | Experimental | to remain sedentary (no planned physical exercise) throughout the duration of the 10% weight loss phase of the study Receives: Behavioral: No Exercise (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
a hyperinsulinemic-euglycemic clamp will be used to quantify peripheral insulin sensitivity
Measured: 2 hours
Fatty acid turnover
stable isotope tracer infusion methods will be used to assess fatty acid turnover
Measured: 2 hours
Adipose tissue capillarization
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software
Measured: 30 minutes
Adipose tissue fibrosis
measured histologically using Sirus Red Staining, quantified using ImageJ software
Measured: 30 minutes
Secondary outcomes (3)
Body weight change
Change in body weight will be assessed 6 months after completing the 10% weight loss intervention
Measured: 6 months
Body fat mass
Body fat mass will be measured by Dual Energy X-ray Absorptiometry (DEXA)
Measured: 30 minutes
Oral Glucose Tolerance Test (OGTT)
A test in which glucose is given and blood samples taken afterward to determine how quickly it is cleared from the blood will be completed at each clinical visit appointment
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start19 Jul 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
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 Horowitz, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806801
- Sponsor's protocol ID
- HUM00220220
- Acronym
- WAX
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2023
- Last updated
- 14 Apr 2026
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Adaptations to Weight Loss With and Without Exercise
- ClinicalTrials.gov ID
- NCT05806801
- Acronym / sponsor ID
- WAX / HUM00220220
- Conditions
- Obesity, Metabolic Disease, Metabolic Syndrome, Insulin Sensitivity, Insulin Resistance, Weight Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 10 Apr 2023 (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.
Study Purpose:
The combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. A deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment/prevention of obesity-related diseases.
Although a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. This is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. We argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained
Study Summary:
10% Weight Loss Phase - Subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). During this, subjects will be randomized into one of two different experimental groups:
- Moderate Intensity Continuous Training (MICT) exercise group
- No exercise (control) group
Follow-up Phase: After completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise/physical activity behavior. Subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss.
Total involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Continuous Training (MICT) exercise group | Experimental | Behavioral: MICT Exercise45 minutes of continuous steady-state exercise at 70% maximal heart rate throughout the 10% weight loss phase of the study |
| No exercise (Control) | Experimental | Behavioral: No Exercise (Control)to remain sedentary (no planned physical exercise) throughout the duration of the 10% weight loss phase of the study |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18-40
- Body Mass Index: 30-40 kg/m2
- Weight stable (±3kg for greater than or equal to about 2 months)
- No regularly planned exercise/physical activity
- Women must have regularly occurring menses and must be premenopausal
Key exclusion criteria (9 listed)
- EKG abnormalities
- Evidence/history of cardiovascular disease, diabetes or other metabolic disease
- Medications known to affect lipid or glucose metabolism
- Pregnant or lactating
- Tobacco or e-cigarette use
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 |
|---|---|---|
| MICT ExerciseSubjects randomized into this group will complete a moderate intensity continuous exercise 4 days/week. | Behavioural | Moderate Intensity Continuous Training (MICT) exercise group |
| No Exercise (Control)Subjects randomized into this group will remain sedentary throughout the duration of the study. | Behavioural | No exercise (Control) |
Primary outcome
Insulin sensitivity
Time frame: 2 hours
a hyperinsulinemic-euglycemic clamp will be used to quantify peripheral insulin sensitivity
Fatty acid turnover
Time frame: 2 hours
stable isotope tracer infusion methods will be used to assess fatty acid turnover
Adipose tissue capillarization
Time frame: 30 minutes
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software
Adipose tissue fibrosis
Time frame: 30 minutes
measured histologically using Sirus Red Staining, quantified using ImageJ software
3 secondary outcomes
Body weight change
Time frame: 6 months
Body fat mass
Time frame: 30 minutes
Oral Glucose Tolerance Test (OGTT)
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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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.
Jeffrey Horowitz, PhD 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 MICT Exercise in people with Obesity and Metabolic Disease, 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzette M Howton (734-647-9850, suzetter@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 2 hours). The study lists 4 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 14 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.