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Recruiting NCT04812314

Exercise Effects on Adipose Tissue Structure and Function

No phase Interventional Obesity Metabolic Syndrome Metabolic Disease Insulin Resistance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise, No exercise.
Who it may be relevant to
Registry conditions: Obesity, Metabolic Syndrome, Metabolic Disease, Insulin Resistance. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Exercise
    Participants will complete a moderate intensity continuous exercise 4 days/week.
  • Behavioral No exercise
    Participants will remain sedentary throughout the duration of the study.

Primary outcome measures

  • Oral Glucose Tolerance Test (OGTT) [Time frame: 2 hours]
  • Adipose Tissue Fibrosis [Time frame: 30 minutes]
  • Muscle Capillarization [Time frame: 30 minutes]
  • Adipose Capillarization [Time frame: 30 minutes]
  • Fat Cell Size [Time frame: 3 minutes]
Secondary outcome measures (2)
  • Blood Lipid Profile [Time frame: 15 minutes]
  • Blood Pressure [Time frame: 10 minutes]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT04812314 · HUM00175528

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗