ObesityNCT07031297
Upper Body Subcutaneous Exosome Release in Response to a Meal in Obesity
A study testing Meal Study in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to understand the specific outflow and difference between normal weight and volunteers with obesity of upper body subcutaneous adipose tissue in response to a mixed meal challenge by site specific cannulation of the superior epigastric vein. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Meal Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2026to May 2028
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women must be premenopausal
Who cannot join
- Participants taking medications know to affect blood flow (statins, β-blockers) or fatty acid or adipose tissue metabolism (TZDs, high dose fish oil supplements)
- Diabetes, history of cardiovascular disease
- Allergy to lidocaine
- Post-menopausal women
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Kelli A Lytle
About this study
Official title: Upper Body Subcutaneous Adipose Tissue Outflow Response to a Meal
The purpose of this study is to understand the specific outflow and difference between normal weight and volunteers with obesity of upper body subcutaneous adipose tissue in response to a mixed meal challenge by site specific cannulation of the superior epigastric vein. We will characterize the exosome signatures in response to a meal and compare to the exosome signature of arterialized venous plasma samples.
- Conditions
- Obesity
- Being tested
- Meal Study
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal StudyDiagnostic test
Participants will consume a mixed meal drink (Ensure) equivalent to 40% of basil metabolic rate as calculated via Harris Benedict equation.
Following consumption of the drink they will undergo a series of blood draws over the following 4 hours:
- Plasma glucose will be measured according to a mixed meal test protocol every 10 minutes for the first hour and then every 15, then 30 minutes for the last 3 hours.
- 1 ml plasma aliquots for exosome analysis and insulin concentrations will be drawn every 30 minutes following consumption of ensure for 4 hours.
- Blood gasses will be drawn every 30 minutes for the 4 hours following the meal.
Participants will undergo a second abdominal adipose tissue biopsy 3 hours following mixed meal drink.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight group | Other | 5 male and 5 female volunteers in normal weight range Receives: Diagnostic Test: Meal Study |
| Obesity group | Other | 5 male and 5 female volunteers with obesity (BMI 29.0-35.0 kg/m2) Receives: Diagnostic Test: Meal Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue blood flow
Blood flow will be measured in the upper body subcutaneous adipose tissue using Xenon washout and reported as blood flow in ml/min/100g adipose tissue.
Measured: 4 hours
Secondary outcomes (1)
Glucose
Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL, results reported in mg/dL
Measured: Baseline, 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start5 May 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelli A. Lytle, Mayo Clinic
- Investigators
- Kelli A. Lytle, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031297
- Sponsor's protocol ID
- 24-007465
- Status last verified
- Jul 2026
- First submitted
- 23 May 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Body Subcutaneous Adipose Tissue Outflow Response to a Meal
- ClinicalTrials.gov ID
- NCT07031297
- Acronym / sponsor ID
- 24-007465
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 Jun 2025 (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 study is to understand the specific outflow and difference between normal weight and volunteers with obesity of upper body subcutaneous adipose tissue in response to a mixed meal challenge by site specific cannulation of the superior epigastric vein. We will characterize the exosome signatures in response to a meal and compare to the exosome signature of arterialized venous plasma samples.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight group | Other | Diagnostic Test: Meal Study5 male and 5 female volunteers in normal weight range |
| Obesity group | Other | Diagnostic Test: Meal Study5 male and 5 female volunteers with obesity (BMI 29.0-35.0 kg/m2) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women must be premenopausal
Key exclusion criteria (5 listed)
- Participants taking medications know to affect blood flow (statins, β-blockers) or fatty acid or adipose tissue metabolism (TZDs, high dose fish oil supplements)
- Diabetes, history of cardiovascular disease
- Allergy to lidocaine
- Post-menopausal women
- Pregnant
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 |
|---|---|---|
| Meal StudyParticipants will consume a mixed meal drink (Ensure) equivalent to 40% of basil metabolic rate as calculated via Harris Benedict equation. Following consumption of the drink they will undergo a series of blood draws over the following 4 hours: * Plasma glucose will be measured according to a mixed meal test protocol every 10 minutes for the first hour and then every 15, then 30 minutes for the last 3 hours. * 1 ml plasma aliquots for exosome analysis and insulin concentrations will be drawn every 30 minutes following consumption of ensure for 4 hours. * Blood gasses will be drawn every 30 minutes for the 4 hours following the meal. Participants will undergo a second abdominal adipose tissue biopsy 3 hours following mixed meal drink. | Diagnostic test | Normal weight group, Obesity group |
Primary outcome
Adipose tissue blood flow
Time frame: 4 hours
Blood flow will be measured in the upper body subcutaneous adipose tissue using Xenon washout and reported as blood flow in ml/min/100g adipose tissue.
1 secondary outcome
Glucose
Time frame: Baseline, 4 hours
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 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Kelli A. Lytle, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal Study in people with Obesity, run by Mayo Clinic at 1 site 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 1 inclusion and 5 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 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Kelli A. Lytle, Ph.D. (507-255-1488, lytle.kelli@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipose tissue blood flow (time frame: 4 hours). 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 5 Aug 2026.