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

NCT06602141 | Recruiting DMC

• 1 other identifier: 1805407
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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

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

Study Arms (2)

Control (CTRL) group

ACTIVE COMPARATOR

Procedure: Muscle Biopsy; Procedure: Adipose Biopsy; Other: Glucose Clamp; Other: Accelerometer; Other: Physical activity/ dietary habits; Other: Heavy Water Labeling Period

Endurance exercise (EX) group

ACTIVE COMPARATOR

Procedure: Muscle Biopsy; Procedure: Adipose Biopsy; Other: Glucose Clamp; Other: Accelerometer; Other: Endurance Exercise; Other: Heavy Water Labeling Period

Interventions

Muscle Biopsy PROCEDURE

This procedure is used to sample muscle cells from the leg Vastus Lateralis (thigh) muscle.

Control (CTRL) group; Endurance exercise (EX) group

Adipose Biopsy PROCEDURE

This procedure is used to sample fat tissue from the abdomen (belly).

Control (CTRL) group; Endurance exercise (EX) group

Glucose Clamp OTHER

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.

Control (CTRL) group; Endurance exercise (EX) group

Accelerometer OTHER

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.

Control (CTRL) group; Endurance exercise (EX) group

Endurance Exercise OTHER

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.

Endurance exercise (EX) group

Physical activity/ dietary habits OTHER

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.

Control (CTRL) group

Heavy Water Labeling Period OTHER

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.

Control (CTRL) group; Endurance exercise (EX) group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and pre-menopausal women;
• 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;
• Able to speak and understand written and spoken English;
• Sedentary defined as self-reporting no more than 1 day per week, lasting no more than 60 minutes, of regular (structured) endurance or resistance exercise in the past year.
• Must be willing to be randomized to either study group;
• Must be willing to adhere to all study procedures.
• Participant has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.

You may not qualify if:

• 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;
• Fasting blood glucose ≥126 mg/dL;
• HbA1c ≥ 6.5%
• Blood pressure \>140/90 mmHg ;
• Self-reported history or presence of the following cardiovascular conditions: congestive heart failure, coronary artery disease, significant valvular disease, congenital heart disease, serious arrhythmia, stroke, symptomatic peripheral artery disease, stable angina, myocardial infarction or coronary revascularization within 6 months; clinically significant abnormalities on ECG, presence of cardiac pacemaker, or implanted cardiac defibrillator; inability to complete the VO2max test;
• Anemia (hemoglobin \<12 g/dl in men or 11 g/dl in women; Hct \<34%);
• Kidney disease (creatinine \>1.6 mg/dl or estimated glomerular filtration rate \<60 mL/min/1.73m2);
• Abnormal liver enzymes (\>2 times the upper limit of normal) that are clinically significant;
• Serious digestive disorders including severe gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), Crohn's disease, chronic constipation and/or diarrhea, etc.;
• Self-reported chronic, active, or latent infection requiring chronic antibiotic or anti-viral treatment; Human Immunodeficiency Virus (HIV); active hepatitis B or C undergoing antiviral therapy;
• Current or history of eating disorders;
• Abnormal bleeding or coagulopathy (self-report) or history of a bleeding disorder or clotting abnormality;

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead
• Pennington Biomedical Research Center: collaborator

Study Sites (2)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

RECRUITING

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

NOT YET RECRUITING

Related Links

• AdventHealth Translational Research Institute website

MeSH Terms

Conditions

Obesity

Interventions

Glucose Clamp Technique; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Investigative Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lauren Sparks, PhD

  AdventHealth Translational Research Institute

  PRINCIPAL INVESTIGATOR

• Ursula White, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Recruitment Department

CONTACT

407-303-7100; CFD.TRI.Recruitment@AdventHealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be randomized into either the control (CTRL) group or the endurance exercise (EX) group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: September 19, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (2)