ObesityATLASNCT06602141
Assessments of Adipogenesis, Lipid Turnover and Cellular Composition in Adipose Tissue in Response to Endurance Exercise
A study testing Muscle Biopsy, Adipose Biopsy and Glucose Clamp in people with Obesity, run by AdventHealth Translational Research Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Muscle Biopsy, Adipose Biopsy and Glucose Clamp
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2024to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
- 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.
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- 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.
Who cannot join
- 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%
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- 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;
- Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD);
- Dyslipidemia (fasting triglycerides >500 mg/dL; low-density lipoprotein cholesterol (LDL-C) >190 mg/dL);
- Whole blood donation in the last 3 months or platelet/plasma donation in the last week or plans for donation during entire protocol period;
- Receiving active treatment (including monoclonal antibodies) for autoimmune disorders within the last 6 months;
- Alcohol consumption >7 drinks per week for women or 14 drinks per week for men or history of binge drinking (≥5 drinks for males or 4 drinks for females in a 2-hour period more than once per month);
- Current smokers (smoking or use of any tobacco or e-cigarette/e-nicotine/THC/cannabis products in the last 3 months); stopped smoking <10 years at time of screening for those with a >20 pack-year smoking history or stopped smoking <5 years at time of screening for those with a <20 pack-year smoking history;
- Night shift work in the last 6 months or planning night shift work during the study period;
- Known allergy to lidocaine or other local anesthetic;
- Hyperthyroidism including those with normal TSH (0.35-4.5) on pharmacological treatment; individuals with hypothyroidism may be referred to their primary care provider for evaluation and retested; any medication change for hypothyroidism must be stable for ≥3 months prior to retesting;
- Previous bariatric or other surgery for obesity;
- History of cancer (other than non-melanoma skin cancer) within the last 5 years (not in remission); anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months;
- Diagnosed psychotic or psychiatric conditions prohibiting adherence to study protocol; hospitalization for any psychotic or psychiatric condition within one year;
- Currently pregnant (pregnancy test performed on day of DEXA scan in women of child-bearing potential); post-partum during the last 12 months; lactating during the last 12 months; planning to become pregnant during the participation period;
- Polycystic Ovarian Syndrome (PCOS) (self-report);
- Metabolic bone disease (self-report) including history of non-traumatic fracture from a standing height or less and/or current pharmacologic treatment for low bone mass or osteoporosis, other than calcium, vitamin D, or estrogen;
- Hospitalization for COVID-19 infection in the past 12 months; individuals who tested positive for COVID-19 but were not hospitalized must be symptom-free at least 14 days;
- Partial and/or full hysterectomy (self-report);
- Not willing to archive biospecimens for future use;
- Not willing to undergo the microdialysis procedure;
- Participants who fulfill any of the contraindications for MRI including metal implants, devices, paramagnetic objects contained within the body and excessive or metal-containing tattoos;
- Unable to participate in MR assessments due to claustrophobia or physical limitations of equipment tolerances (e.g., MRI bore size) based on investigator's judgment at screening;
- Positive toxicology result from screening;
- The following medication use is exclusionary:
- Dose change for any chronic-use drug in the last 3 months;
- Cardiovascular: beta blockers and centrally acting anti-hypertensive drugs, anticoagulants, antiarrhythmics, and antiplatelet drugs (other than aspirin ≤100 mg/day);
- Psychiatric: chronic use of medium- or long-acting sedatives and hypnotics, including all benzodiazepines (short-acting non-benzodiazepine sedative-hypnotics are allowed), mood stabilizers, antiepileptic drugs, stimulants, Attention-Deficit/Hyperactivity Disorder (ADHD) drugs, anti-psychotic drugs;
- Pulmonary/Inflammation: chronic oral steroids (inhaled steroids are allowed), burst/taper oral steroids more than once in the last 12 months, B2-agonists (allowed if on stable dose at least 3 months);
- Genitourinary: 5-alpha reductase inhibitors, daily phosphodiesterase type 5 inhibitor;
- Hormonal: androgenic anabolic steroids, anti-estrogens, anti-androgens, estrogens and/or progestins used for reasons other than birth control, growth hormone, insulin like growth factor-I, growth hormone releasing hormone, any drugs used to treat diabetes mellitus or lower blood glucose, metformin for any indication, any drugs used specifically to induce weight loss, any drugs used specifically to induce muscle growth/hypertrophy or augment exercise-induced muscle hypertrophy;
- Pain/Inflammation: narcotics and narcotic receptor agonists, regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen, muscle relaxants ≥2 days per week;
- Other: chronic systemic antimicrobials (antibiotic, antiviral, antifungal, antiparasite, etc.) for any reason, high-potency topical steroids if ≥10% surface area using rule of 9s, continuous/chronic use of antibiotics or other anti-infectives for treatment or prevention, monoclonal antibodies, anti-rejection medications/immune suppressants;
- Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Ursula White, PhD, ursula.white@pbrc.edu
Ursula White, PhD
- Recruiting
AdventHealth Translational Research Institute
Orlando, Florida, 32804
Recruitment Department, 407-303-7100
Lauren Sparks, PhD
About this study
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
- Being tested
- Muscle Biopsy, Adipose Biopsy, Glucose Clamp, Accelerometer, Endurance Exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle BiopsyProcedure or surgery
This procedure is used to sample muscle cells from the leg Vastus Lateralis (thigh) muscle.
Adipose BiopsyProcedure or surgery
This procedure is used to sample fat tissue from the abdomen (belly).
Glucose ClampOther
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.
AccelerometerOther
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 ExerciseOther
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 habitsOther
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 PeriodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control (CTRL) group | Active comparator | Not described Receives: 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 | Not described Receives: Procedure: Muscle Biopsy; Procedure: Adipose Biopsy; Other: Glucose Clamp; Other: Accelerometer; Other: Endurance Exercise; Other: Heavy Water Labeling Period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before and following 12 weeks of deuterium (2H) labelled water administration and either endurance exercise training or control (no exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start11 Sep 2024
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Sponsor
- Investigators
- Lauren Sparks, PhD, Principal investigator, AdventHealth Translational Research InstituteUrsula White, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602141
- Sponsor's protocol ID
- 1805407
- Acronym
- ATLAS
- Status last verified
- Mar 2026
- First submitted
- 19 Aug 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessments of Adipogenesis, Lipid Turnover and Cellular Composition in Adipose Tissue in Response to Endurance Exercise
- ClinicalTrials.gov ID
- NCT06602141
- Acronym / sponsor ID
- ATLAS / 1805407
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
- Able to speak and understand written and spoken English;
Key exclusion criteria (47 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle BiopsyThis procedure is used to sample muscle cells from the leg Vastus Lateralis (thigh) muscle. | Procedure or surgery | Control (CTRL) group, Endurance exercise (EX) group |
| Adipose BiopsyThis procedure is used to sample fat tissue from the abdomen (belly). | Procedure or surgery | Control (CTRL) group, Endurance exercise (EX) group |
| Glucose ClampIn this test, we will measure the effect of insulin by giving you insulin and glucose (sugar) intravenously through an IV line in your arm. | Other | Control (CTRL) group, Endurance exercise (EX) group |
| AccelerometerThe 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. | Other | Control (CTRL) group, Endurance exercise (EX) group |
| Endurance ExerciseVisit 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. | Other | Endurance exercise (EX) group |
| Physical activity/ dietary habitsVisit the study site bi-weekly to get weight measurements and speak to the study team about weight maintenance and participant physical activity/dietary habits. | Other | Control (CTRL) group |
| Heavy Water Labeling PeriodParticipants 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. | Other | Control (CTRL) group, Endurance exercise (EX) group |
Primary outcome
In vivo adipogenesis
Time frame: Before and following 12 weeks of deuterium (2H) labelled water administration and either endurance exercise training or control (no exercise)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- AdventHealth Translational Research Institute websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Sparks, PhD principal investigator
AdventHealth Translational Research Institute
Ursula White, PhD principal investigator
Pennington Biomedical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Biopsy, Adipose Biopsy and Glucose Clamp in people with Obesity, run by AdventHealth Translational Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Recruitment Department (407-303-7100, CFD.TRI.Recruitment@AdventHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vivo adipogenesis (time frame: Before and following 12 weeks of deuterium (2H) labelled water administration and either endurance exercise training or control (no exercise)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.