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Upper Body Subcutaneous Exosome Release in Response to a Meal in Obesity

Upper Body Subcutaneous Adipose Tissue Outflow Response to a Meal

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07031297
Enrollment
20
Registered
2025-06-22
Start date
2026-05-05
Completion date
2028-05-01
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief 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. We will characterize the exosome signatures in response to a meal and compare to the exosome signature of arterialized venous plasma samples.

Interventions

DIAGNOSTIC_TESTMeal Study

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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

• All women must be premenopausal

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Adipose tissue blood flow4 hoursBlood 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.

Secondary

MeasureTime frameDescription
GlucoseBaseline, 4 hoursSugar 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

Countries

United States

Contacts

CONTACTKelli A. Lytle, Ph.D.
lytle.kelli@mayo.edu507-255-1488
PRINCIPAL_INVESTIGATORKelli A. Lytle, Ph.D.

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026