ClinicalTrials.gg
RecruitingNCT04812314LGUpdated Jun 4, 2026

Exercise Effects on Adipose Tissue Structure and Function

An interventional study of Exercise and No exercise in Obesity, Metabolic Syndrome and Metabolic Disease, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by University of Michigan · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Mar 2021; still recruiting 5 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obesity
  • Metabolic Syndrome
  • Metabolic Disease
  • Insulin Resistance
  • Weight Loss
  • Weight Gain
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 46 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Age: 18-40
  • : 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Exercise

    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.

    Behavioral: Exercise

  • Experimental
    No exercise

    Subjects assigned to this group are to remain sedentary (no planned physical exercise) throughout the duration of the study.

    Behavioral: No exercise

Interventions

  • BehavioralExercise

    Participants will complete a moderate intensity continuous exercise 4 days/week.

  • BehavioralNo exercise

    Participants will remain sedentary throughout the duration of the study.

    Also known as: Control group

06

What researchers measure

Primary outcomes

  1. 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..

    Time frame: 2 hours

  2. Adipose Tissue Fibrosis

    measured histologically using Sirus Red Staining, quantified using ImageJ software at each clinical visit appointment.

    Time frame: 30 minutes

  3. Muscle Capillarization

    measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.

    Time frame: 30 minutes

  4. Adipose Capillarization

    measured immunohistochemically using an antibody for CD31, quantified using ImageJ software at each clinical visit appointment.

    Time frame: 30 minutes

  5. Fat Cell Size

    measured histologically using Hematoxylin and eosin (H \& E) staining, quantified using ImageJ software at each clinical visit appointment.

    Time frame: 3 minutes

Secondary outcomes

  1. Blood Lipid Profile

    A panel of blood tests that screens for abnormalities in blood lipids will be measured at each clinical visit appointment.

    Time frame: 15 minutes

  2. Blood Pressure

    The pressure of circulating blood against the walls of blood vessels will be measured at screening and each clinical visit appointment.

    Time frame: 10 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — There is not a plan to make IPD available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04812314
Responsible party
Jeffrey F Horowitz (professor of Movement Science and director of the Substrate Metabolism Laboratory (SML) at the University of Michigan School of Kinesiology, University of Michigan) — Principal investigator
First posted
Mar 23, 2021
Start date
Mar 1, 2021
Primary completion
Mar 1, 2028 (estimated)
Completion
Mar 1, 2030 (estimated)
Last update
Jun 4, 2026

Study contacts

Suzette Howton
Contact
smlstudies@umich.edu
734-647-9850
Jeffrey F Horowitz, PhD
principal investigator · University of Michigan, School of Kinesiology

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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