Upper Body Subcutaneous Exosome Release in Response to a Meal in Obesity
Upper Body Subcutaneous Adipose Tissue Outflow Response to a Meal
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 22, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
April 28, 2026
April 1, 2026
2 years
May 23, 2025
April 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
4 hours
Secondary Outcomes (1)
Glucose
Baseline, 4 hours
Study Arms (2)
Normal weight group
OTHER5 male and 5 female volunteers in normal weight range
Obesity group
OTHER5 male and 5 female volunteers with obesity (BMI 29.0-35.0 kg/m2)
Interventions
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.
Eligibility Criteria
You may qualify if:
- All women must be premenopausal
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelli A Lytle
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 23, 2025
First Posted
June 22, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share