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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Diagnostic test: Meal Study

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Normal weight group; 5 male and 5 female volunteers in normal weight range	Diagnostic test: Meal 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.
Other: Obesity group; 5 male and 5 female volunteers with obesity (BMI 29.0-35.0 kg/m2)	Diagnostic test: Meal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 4 hours

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kelli A Lytle, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: May 23, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: 24-007465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No