Assessments of Adipogenesis, Lipid Turnover and Cellular Composition in Adipose Tissue in Response to Endurance Exercise

ConditionObesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-45

SponsorAdventHealth Translational Research Institute

About this trial

The purpose of this research study is to study the effects of endurance exercise training on adipose (fat) tissue quality and insulin sensitivity in men and women.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men and pre-menopausal women;

18-45 years of age;

BMI 30.0-40.0 kg/m2;

For women, if not using pharmaceutical (hormonal) contraception (i.e. birth control pills, vaginal ring, injections, or implant), must agree to use either a double barrier method as a form of birth control to prevent pregnancy (i.e. male condom with spermicide, with or without cervical cap or diaphragm); use implants or intrauterine contraceptive devices; have a tubal ligation (surgically sterile); practice abstinence; or be in an established relationship with a vasectomized or same sex partner during the entire duration of the study;

Disqualifiers

Self-reported unstable body weight in the last 3 months (> ±5%);

Significant changes in the quality of the diet or the level of physical activity within the last 3 months;

Weight >396 lb (180 kg);

Diagnosis of Type 1 or Type 2 diabetes mellitus;

Trial design

Design model

Parallel

Treatments tested in this trial

Muscle Biopsy
Procedure/Surgery
This procedure is used to sample muscle cells from the leg Vastus Lateralis (thigh) muscle.
Adipose Biopsy
Procedure/Surgery
This procedure is used to sample fat tissue from the abdomen (belly).
Glucose Clamp
Other intervention
In this test, we will measure the effect of insulin by giving you insulin and glucose (sugar) intravenously through an IV line in your arm.
Accelerometer
Other intervention
The tri-axial accelerometer measure activity and uses those values to estimate the number of calories burned based on your height, weight, age, and gender. The monitor also evaluates physical effort and the body's response to different activities.
Endurance Exercise
Other intervention
Visit the study site 3 times a week to engage in endurance exercise training for approximately 12 weeks. Each session will last approximately 75 minutes, and exercise group can choose to use either a stationary bike or a treadmill to complete the training.
Physical activity/ dietary habits
Other intervention
Visit the study site bi-weekly to get weight measurements and speak to the study team about weight maintenance and participant physical activity/dietary habits.
Heavy Water Labeling Period
Other intervention
Participants in both control groups will be required to drink heavy water, which is ordinary water that is enriched with deuterium (stable, non-radioactive isotope) and called deuterium-labeled water, for 12 weeks.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Control (CTRL) groupActive comparator 6 interventions

Group B: Endurance exercise (EX) groupActive comparator 6 interventions

Trial outcomes

Primary outcomes

In vivo adipogenesis

A subcutaneous white adipose tissue biopsy from the abdomen will be collected before and after 12 weeks of deuterium (2H) labelled water administration and either endurance exercise training or control (no exercise). New adipocyte formation will be assessed on frozen isolated 2H2O labelled adipose tissue cells

Time frame

Before and following 12 weeks of deuterium (2H) labelled water administration and either endurance exercise training or control (no exercise)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AdventHealth Translational Research Institute

Lead sponsor

Pennington Biomedical Research Center

Collaborator

Source ClinicalTrials.gov

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