ObesityLGNCT04812314
Exercise Effects on Adipose Tissue Structure and Function
A study testing Exercise and No exercise in people with Obesity and Metabolic Syndrome, run by University of Michigan at 1 site in United States.
Trial summary
Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obesity, Metabolic Syndrome, Metabolic Disease
- What is being tested?
- Exercise and No exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Mar 2030
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-40
- Body Mass Index: 27-45 kg/m2
- No regularly planned exercise/physical activity for at least 6 months
- Women must have regularly occurring menses and must be premenopausal
Who cannot join
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism, or inflammation
- Weight instability ≥ ± 6 pounds in the last 3 months
- Tobacco or e-cigarette users
- Women must not be pregnant or actively lactating
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
Jeffrey F Horowitz, 7346471076, jeffhoro@umich.edu
About this study
Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.
Read the detailed description
Exercise is among the first line treatments for obesity and obesity-related diseases, yet it is shocking how little is known about how exercise works to improve health. Expanding the knowledge about novel exercise-induced adaptations in fat tissue of obese individuals and furthering the understanding about mechanisms underlying these adaptations could lead to innovative approaches for preventing and treating insulin resistance and obesity-related diseases.
Overall, the researchers believe that exercise training modifies key processes in subcutaneous fat tissue that may contribute to an increase body fat storage capacity (without increasing fat mass). The research team anticipates that exercise will evoke an even more potent adaptive response when fat tissue is dynamically changing in response to alterations in nutritional status (i.e., weight loss and weight regain).
Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests. After the participant completes the study, the study team will help the participant to lose more weight. Total involvement in the study for each participant will likely be about 8-10 months.
- Conditions
- Obesity, Metabolic Syndrome, Metabolic Disease, Insulin Resistance, Weight Loss, Weight Gain
- Being tested
- Exercise, No exercise
- Medical subject headings
- Obesity, Metabolic Syndrome, Metabolic Diseases, Insulin Resistance, Weight Loss, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will complete a moderate intensity continuous exercise 4 days/week.
No exerciseBehavioural
Also called Control group
Participants will remain sedentary throughout the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | This exercise prescription represents a common or "conventional" form of physical activity (e.g., moderate/brisk walking). If assigned to this group, participants will perform 45 minutes of moderate intensity continuous steady-state exercise at 70% maximal heart rate (HRmax) to expend 250 calories 4 days per week. Receives: Behavioral: Exercise |
| No exercise | Experimental | Subjects assigned to this group are to remain sedentary (no planned physical exercise) throughout the duration of the study. Receives: Behavioral: No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Adipose Tissue Fibrosis
measured histologically using Sirus Red Staining, quantified using ImageJ software at each clinical visit appointment.
Measured: 30 minutes
Muscle Capillarization
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.
Measured: 30 minutes
Adipose Capillarization
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.
Measured: 30 minutes
Fat Cell Size
measured histologically using Hematoxylin and eosin (H \& E) staining, quantified using ImageJ software at each clinical visit appointment.
Measured: 3 minutes
Secondary outcomes (2)
Blood Lipid Profile
A panel of blood tests that screens for abnormalities in blood lipids will be measured at each clinical visit appointment.
Measured: 15 minutes
Blood Pressure
The pressure of circulating blood against the walls of blood vessels will be measured at screening and each clinical visit appointment.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2030 (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
- 46 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 F Horowitz, PhD, Principal investigator, University of Michigan, School of Kinesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812314
- Sponsor's protocol ID
- HUM00175528
- Acronym
- LG
- Status last verified
- Jun 2026
- First submitted
- 19 Mar 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Effects on Adipose Tissue Structure and Function
- ClinicalTrials.gov ID
- NCT04812314
- Acronym / sponsor ID
- LG / HUM00175528
- Conditions
- Obesity, Metabolic Syndrome, Metabolic Disease, Insulin Resistance, Weight Loss, Weight Gain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 23 Mar 2021 (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.
Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.
Detailed description
Exercise is among the first line treatments for obesity and obesity-related diseases, yet it is shocking how little is known about how exercise works to improve health. Expanding the knowledge about novel exercise-induced adaptations in fat tissue of obese individuals and furthering the understanding about mechanisms underlying these adaptations could lead to innovative approaches for preventing and treating insulin resistance and obesity-related diseases.
Overall, the researchers believe that exercise training modifies key processes in subcutaneous fat tissue that may contribute to an increase body fat storage capacity (without increasing fat mass). The research team anticipates that exercise will evoke an even more potent adaptive response when fat tissue is dynamically changing in response to alterations in nutritional status (i.e., weight loss and weight regain).
Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests. After the participant completes the study, the study team will help the participant to lose more weight. Total involvement in the study for each participant will likely be about 8-10 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseThis exercise prescription represents a common or "conventional" form of physical activity (e.g., moderate/brisk walking). If assigned to this group, participants will perform 45 minutes of moderate intensity continuous steady-state exercise at 70% maximal heart rate (HRmax) to expend 250 calories 4 days per week. |
| No exercise | Experimental | Behavioral: No exerciseSubjects assigned to this group are to remain sedentary (no planned physical exercise) throughout the duration of the study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-40
- Body Mass Index: 27-45 kg/m2
- No regularly planned exercise/physical activity for at least 6 months
- Women must have regularly occurring menses and must be premenopausal
Key exclusion criteria (5 listed)
- Evidence/history of cardiovascular or metabolic disease
- Medications known to affect lipid or glucose metabolism, or inflammation
- Weight instability ≥ ± 6 pounds in the last 3 months
- Tobacco or e-cigarette users
- Women must not be pregnant or actively lactating
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 |
|---|---|---|
| ExerciseParticipants will complete a moderate intensity continuous exercise 4 days/week. | Behavioural | Exercise |
| No exerciseAlso: Control groupParticipants will remain sedentary throughout the duration of the study. | Behavioural | No exercise |
Primary outcome
Oral Glucose Tolerance Test (OGTT)
Time frame: 2 hours
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..
Adipose Tissue Fibrosis
Time frame: 30 minutes
measured histologically using Sirus Red Staining, quantified using ImageJ software at each clinical visit appointment.
Muscle Capillarization
Time frame: 30 minutes
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.
Adipose Capillarization
Time frame: 30 minutes
measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.
Fat Cell Size
Time frame: 3 minutes
measured histologically using Hematoxylin and eosin (H \& E) staining, quantified using ImageJ software at each clinical visit appointment.
2 secondary outcomes
Blood Lipid Profile
Time frame: 15 minutes
Blood Pressure
Time frame: 10 minutes
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 4 Jun 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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 F Horowitz, PhD principal investigator
University of Michigan, School of Kinesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and No exercise in people with Obesity and Metabolic Syndrome, 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 4 inclusion and 5 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 4 Jun 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 Howton (734-647-9850, smlstudies@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Glucose Tolerance Test (OGTT) (time frame: 2 hours). The study lists 5 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 4 Jun 2026.