Clinical trial NCT04812314: Exercise Effects on Adipose Tissue Structure and Function
Official title: Exercise Effects on Adipose Tissue Structure and Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Metabolic Disease
Insulin Resistance
Weight Loss
Weight Gain
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Oral Glucose Tolerance Test (OGTT)
timeFrame: 2 hours
measure: Adipose Tissue Fibrosis
timeFrame: 30 minutes
measure: Muscle Capillarization
timeFrame: 30 minutes
measure: Adipose Capillarization
timeFrame: 30 minutes
measure: Fat Cell Size
timeFrame: 3 minutes
Secondary outcomes:
measure: Blood Lipid Profile
timeFrame: 15 minutes
measure: Blood Pressure
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan, School of Kinesiology
name: Jeffrey F Horowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: